PROTISORB® POLYDIOXANONE | PDS SUTURES

PRODUCT INFORMATION

COMPOSITION

100%
Poly(p-dioxanone)

COATING

None

STRUCTURE – COLOR

Monofilament
Violet – Undyed

WOUND SUPPORT

60-90 days

TOTAL ABSORPTION

180-210 days

RETENTION STRENGTH

70-80% @ 2 weeks
60-70% @ 4 weeks
50-60% @ 6 weeks

USP SIZES

7/0 – 1

KNOT-PULL TENSILE STRENGTH

Exceed USP requirements (USP)

SUTURE LENGTH

45 cm, 75 cm
90 cm, 150 cm

STERILISATION

EO
(Ethylene Oxide)

PACKAGING

Aluminum Foil
Box 12 | 36 pcs

INSTRUCTIONS FOR USE

COMPOSITION:

PROTISORB® is a sterile monofilament synthetic absorbable surgical suture composed of a 100% Poly(p-dioxanone). The suture is available dyed with FDA-approved color additive D&C Violet No. 2 – CI 60725 or undyed in the natural beige color.

Polydioxanone is also named as: PDO, PDS Sturures

CHARACTERISTICS:

PROTISORB® provides wound support for 60-90 days. Complete absorption is accomplished by hydrolysis in 180-210 days.

  • High tensile strength, exceeding USP requirements.
  • AISI 300 series stainless steel (for sutures with attached needles).
  • Ease of handling, smooth passage through tissue.

INDICATIONS:

PROTISORB® – Polydioxanone Surgical Sutures (PDS Sutures) are indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.

PROTISORB® is not indicated in adult cardiovascular tissue, microsurgery, and neural tissue.

(A mild inflammatory reaction may occur, which is typical of an endogenous reaction to foreign bodies).

NOTICE:

Sterilized by Ethylene Oxide (EO). Do not re-sterilize | reuse. Do not use if the package is opened or damaged.

STORAGE:

Recommended storage conditions below 25⁰C, away from moisture and direct heat. Do not use after the expiry date. Shelf life: 5 years from the date of manufacturing.

PRODUCT SPECIFICATIONS

No. CPT Code
PROTISORB
Competitor Code
PDS Sutures II
MONOPLUS
MAXON
MONOTIME
Suture Type USP
Size
Suture
Length (cm)
Needle Shape Needle
Length (mm)
Circle How
Supplied
1 PD05LL10 Z1711E | Z135H
W9080T
C0024801
6139-01
8886613901
Polydioxanone 7/0 75 Tapercut CC ×2 10 3/8 Box / 12 pcs
2 PD05BB13L45 W9095T
W9095H
Polydioxanone 7/0 45 Taper Point ×2 13 3/8 Box / 12 pcs
3 PD07BB10L45 W9093H
W9093T
Polydioxanone 6/0 45 Taper Point ×2 10 3/8 Box / 12 pcs
4 PD07LL10 Z1712H
Z1702H
6127-11
8886612711
Polydioxanone 6/0 75 Tapercut CC ×2 10 3/8 Box / 12 pcs
5 PD07A13 W9100H
C0024002
6213-11
8886621311
Polydioxanone 6/0 75 Taper Point 13 1/2 Box / 12 pcs
6 PD07LL13 Z1032H
C0024732
Polydioxanone 6/0 75 Tapercut CC ×2 13 3/8 Box / 12 pcs
7 PDU07E13PL45 6532-11
8886653211
Polydioxanone (U) 6/0 45 Reverse Cutting (P) 13 3/8 Box / 12 pcs
8 PD10AA13 W9201H
C0024603
W9201H
C0024603
6213-21
8886621321
Polydioxanone 5/0 75 Taper Point ×2 13 1/2 Box / 36 pcs
9 PD10BB13 Z1013H
C0024813
6124-21
8886612421
Polydioxanone 5/0 75 Taper Point ×2 13 3/8 Box / 36 pcs
10 PDU10E13PL45 SMM5526 Polydioxanone (U) 5/0 45 Reverse Cutting (P) 13 3/8 Box / 36 pcs
11 PD10A17 C0024013
6207-21
8886620721
Polydioxanone 5/0 75 Taper Point 17 1/2 Box / 36 pcs
12 PD10AA17L90 W9108H
C0024443
Polydioxanone 5/0 90 Taper Point ×2 17 1/2 Box / 36 pcs
13 PDU10C16 W9733T Polydioxanone 5/0 75 Conventional Cutting 16 3/8 Box / 36 pcs
14 PD15A17 C0024014 Polydioxanone 4/0 75 Taper Point 17 1/2 Box / 36 pcs
15 PD15B17 W9077H Polydioxanone 4/0 75 Taper Point 17 3/8 Box / 36 pcs
16 PD15A20 W9115H
C0024134
6217-31
8886621731
88866217-31
14S15A | 14S15H
Polydioxanone 4/0 75 Taper Point 20 1/2 Box / 36 pcs
17 PD15A26 Polydioxanone 4/0 75 Taper Point 26 1/2 Box / 36 pcs
18 PD20A17 Polydioxanone 3/0 75 Taper Point 17 1/2 Box / 36 pcs
19 PD20A20 W9116H | Z311H
14S20H
Polydioxanone 3/0 75 Taper Point 20 1/2 Box / 36 pcs
20 PD20A26 W9124H | Z316H
C0024025
6233-41
8886623341
14S20B
Polydioxanone 3/0 75 Taper Point 26 1/2 Box / 36 pcs
21 PD20E26 Polydioxanone 3/0 75 Reverse Cutting 26 3/8 Box / 36 pcs
22 PD20A40 W9152T Polydioxanone 3/0 75 Taper Point 40 1/2 Box / 36 pcs
23 PD30A26 W9125H
C0024026
6233-51
8886623351
14S30D
Polydioxanone 2/0 75 Taper Point 26 1/2 Box / 36 pcs
24 PD30E26 Polydioxanone 2/0 75 Reverse Cutting 26 3/8 Box / 36 pcs
25 PD30A30 C0024036 Polydioxanone 2/0 75 Taper Point 30 1/2 Box / 36 pcs
26 PD30M36 W9380H
Z339H
C0024046
Polydioxanone 2/0 75 Tapercut 36 1/2 Box / 36 pcs
27 PD30A40 W9151T Polydioxanone 2/0 75 Taper Point 40 1/2 Box / 36 pcs
28 PD35D36 6755-61
8886675561
Polydioxanone 0 75 Reverse Cutting 36 1/2 Box / 36 pcs
29 PD35M36L90 W9381H
C0024517
6269-71
8886626971
Polydioxanone 0 90 Tapercut 36 1/2 Box / 36 pcs
30 PD35A40 W9233T
6287-61
14S35E
Monomax B0041097
Polydioxanone 0 75 Taper Point 40 1/2 Box / 36 pcs
31 PD35A40HL150 W9236T Polydioxanone 0 150 Taper Point (H) 40 1/2 Box / 36 pcs
32 PD40A40L90 W9234T
6287-71
8886628771
14S40B
Polydioxanone 1 90 Taper Point 40 1/2 Box / 36 pcs
33 PDA40M40L150 PDP1935T Polydioxanone (A) 1 150 Tapercut 40 1/2 Box / 36 pcs
34 PD500 Polydioxanone 2 150 Without needle Box / 36 pcs