Suture, Nonabsorbable, Synthetic, Polyethylene

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Shandong, Shanghai and Beijing, and 1 other province: 6 hold an FDA registration.

ARC Medical Supplies (Beijing) Co., Ltd. Beijing
Arthrex (Shanghai) Co., Ltd. Shanghai
Foosin Medical Supplies Inc.ltd Shandong
Shandong Haidike Medical Products Co., Ltd. Shandong
Xiamen Zhiyuan Medical Technology Co., Ltd. Fujian, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is GAT Classified?

Suture, Nonabsorbable, Synthetic, Polyethylene is FDA product code GAT, Class 2, 21 CFR 878.5000.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 140 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 23 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Employee error (8), Packaging process control (4) and Device Design (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Suture, Nonabsorbable, Synthetic, Polyethylene

Deknatel

Green Braided PTFE Impregnated Polyester Fiber Size 6-0 36" KT-1 Needle K-2 Needle SybronEndo

Suture, Nonabsorbable, Synthetic, Polyethylene

Silkam

Silkam Black 7/0 (0.5) 45CM 2XDSMP11 (M)

Suture, Nonabsorbable, Synthetic, Polyethylene

Premicron

Premicron Green 2/0 (3) 75CM DS24(M) DDP

Suture, Nonabsorbable, Synthetic, Polyethylene

HI-FI

H-Fi 1 White Braided and 1 White/Blue Co-braid Size 2 40" HC-5 Needle ConMed

Suture, Nonabsorbable, Synthetic, Polyethylene

Ti-Cron

Coated Braided Polyester, CV-305, D/A, 4Blue/4White Strands with Soft PTFE Pledget 3x6x1.65

Suture, Nonabsorbable, Synthetic, Polyethylene

DemeDAC

Polyester Multifilament,Uncoated, Sterile, Nonabsorbable Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

HyperSuture

2mm Green/White UHMWPE Whip Stich Suture Tape Loop, 24" w/ 45mm Trocar Needle

Suture, Nonabsorbable, Synthetic, Polyethylene

DemeBOND

Polyester Multifilament Coated,Braided, Sterile, Nonabsorbable Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Ethibond Excel

Braided Polybutilate Coated Polyester, Synthetic Non-Absorbable Surgical Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

HS Suture Tape

11 catalogue numbers from HS208, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Force Fiber

Force Fiber Blue Braided Size 2 36" HC-5 Needle, C-12 Needle Tornier

Suture, Nonabsorbable, Synthetic, Polyethylene

HS FIber

Blue/White UHMWPE Polyblend Braided Non-Absorbable Suture Tape

Suture, Nonabsorbable, Synthetic, Polyethylene

Infinity-Lock 5

Infinity-Lock 5 is a sterile, nonabsorbable polyester tape for soft-tissue approximation, including repair of acute Achilles-tendon rupture. It is woven from polyethylene terephthalate…

Suture, Nonabsorbable, Synthetic, Polyethylene

Arthrex®

FiberLink SutureTape 0.9mm Blue w/ Ndl, Arthrex

Suture, Nonabsorbable, Synthetic, Polyethylene

Teleflex

Blue braided Size 2 K-61 N White braided 2 K-61 White/blue co-braid 2 White braided 5 HSCX48 N White/Blue co-braid 5 HSCX48 N White braided 5 MAXBRAID Biomet

Suture, Nonabsorbable, Synthetic, Polyethylene

Supolene

26 catalogue numbers from SUPOLENE, listed by Resorba Medical GmbH, Germany, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

FlexiGRAFT®

QuadLink™ (10.5 x 61 mm). Sutured quadriceps tendon construct.

Suture, Nonabsorbable, Synthetic, Polyethylene

Hi-Fi

53 catalogue numbers from HS5200, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

ForceBraid

12 catalogue numbers from HS122, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Mersilene

Mersilene Polyester Fiber Ligature, White Woven, Sterile, Nonabsorbable Surgical Ligature

Suture, Nonabsorbable, Synthetic, Polyethylene

WEGO-Polyester Nonabsorbable Surgical Suture With Needle

175 catalogue numbers from E41192, listed by Foosin Medical Supplies Inc.ltd, China, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Cardioxyl ®

162 catalogue numbers from 73I10C, listed by Peters Surgical, France, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

ALLthread Titanium

6 catalogue numbers from 902610, listed by Biomet Orthopedics, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Endobutton

Endobutton CL Fixation Button With 25 MM Continuous Loop Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

MaxBraid PE Suture

10 catalogue numbers from ZB-HS527, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Novostitch

NovoStitch Plus Meniscal Repair System

Suture, Nonabsorbable, Synthetic, Polyethylene

Smartstitch M-Connector

OM-8085EA Speedstitch Suture Cartridge F

Suture, Nonabsorbable, Synthetic, Polyethylene

Parcus Braid

Sterile Infinity Loop Parcus Braid 2 w/ Needle

Suture, Nonabsorbable, Synthetic, Polyethylene

DemeFORCE

DemeFORCE Nonabsorbable Surgical Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Rtmed

39 catalogue numbers from 0# Without Needle 150cm, listed by Shandong Haidike Medical Products Co., Ltd., China, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

V-Loc

Polybutester (PBT) Nonabsorbable Knotless Wound Closure Device

Suture, Nonabsorbable, Synthetic, Polyethylene

Vascufil

Coated Monofilament Polybutester,CV-Coated Monofilament Polybutester

Suture, Nonabsorbable, Synthetic, Polyethylene

Dagrofil

Dagrofil Green 2/0 (3) 75CM DS24 (M) DDP

Suture, Nonabsorbable, Synthetic, Polyethylene

Polybond

38 catalogue numbers from CP1080A, listed by C P Medical Inc., under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

AnchorKnot Suture

Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.

Suture, Nonabsorbable, Synthetic, Polyethylene

XBraid S

Suture Shuttle

Suture, Nonabsorbable, Synthetic, Polyethylene

LV-493B

Salvin 5-0 PGA C3(P3) Needle Synthetic

Suture, Nonabsorbable, Synthetic, Polyethylene

ApeCord

White/Black UHMWPE Polyblend Non-Absorbable Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Fssb

2xHRS-25.0-680P USP 2-0 Polyester green 90 cm. with Pledget 3x6 mm. 24 pcs. Per Box. sterile

Suture, Nonabsorbable, Synthetic, Polyethylene

Ultrabraid

ULTRABRAID No.2 WHITE SUTURE AND NEEDLE ASSEMBLY, 38 INCH, 10 PER BOX, STERILE

Suture, Nonabsorbable, Synthetic, Polyethylene

PowerSuture Tape

Meniscal Needles – Double Armed, Blue Braided UHMWPE Non-Absorbable Suture Tape

Suture, Nonabsorbable, Synthetic, Polyethylene

Endure Industries

Endure Sutures NYLON Blue, 60mm, Straight Cutting, 75cm, 2-0

Suture, Nonabsorbable, Synthetic, Polyethylene

MaxBraid With RigidStitch

6 catalogue numbers from 110045777, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

XBraid

2.0MM Xbraid TT, 100% Uhmwpe, Violet Co-Braid

Suture, Nonabsorbable, Synthetic, Polyethylene

Orthocord

2-0 ORTHOCORD w/Double-Armed Meniscal Needles ORTHOCORD Violet braided composite suture, Size 2-0 (3 metric), 38 Inches (96.5cm), Double - Armed with 13 Inches (33cm) meniscal needles (2).

Suture, Nonabsorbable, Synthetic, Polyethylene

JRF GraftLink XL

JRF GraftLink XL: 1 catalogue number listed by Joint Restoration Foundation Inc, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Novafil

Monofilament Polybutester,CV-11,D/A,1x Blue Strand

Suture, Nonabsorbable, Synthetic, Polyethylene

Aztron Suture Tape

1.2mm White/Blue/Black Polyblend Surgical Suture Tape, 36"

Suture, Nonabsorbable, Synthetic, Polyethylene

Magnumwire

Magnumwire Loose Nonabsorbable Suture Blue-Cobraid With 26.5 MM 1/2 Circle Tapered Needle

Suture, Nonabsorbable, Synthetic, Polyethylene

Smartstitch Perfectpasser

Smartstitch Perfectpasser Magnumwire Suture Cartridges, Black Co-Braid

Suture, Nonabsorbable, Synthetic, Polyethylene

XBraid TT

3910-900-125S

Suture, Nonabsorbable, Synthetic, Polyethylene

Bluestitch

White Blue Co-braid Polyethylene Size 0 20" HR17X CRE

Suture, Nonabsorbable, Synthetic, Polyethylene

SutUp

15 catalogue numbers from HS1062-MU, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Zipline

White/Black Co-braid Size 2 36" Pivot

Suture, Nonabsorbable, Synthetic, Polyethylene

LoopLock

2 catalogue numbers from HS518, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

DFX Tensile Tape

DFX Tensile Tape is a flat braided suture used to approximate or ligate soft tissue, including allograft tissue in orthopedic surgery. It is made from ultra-high molecular weight…

Suture, Nonabsorbable, Synthetic, Polyethylene

McKesson

Suture, Ethbnd X GRN BR 5-0 36" RB-1 B556H(36/BX)

Suture, Nonabsorbable, Synthetic, Polyethylene

Split Stitch

5 catalogue numbers from HS-2C-SS, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Onatec

Onabond 2 arm(s)2xVSPM(LZ)-8-350 6/0, 45 cm PEW

Suture, Nonabsorbable, Synthetic, Polyethylene

Fastloop™ Green

Polyester Suture Loop Green with Needle

Suture, Nonabsorbable, Synthetic, Polyethylene

ReConnex™

ReConnex™ Pre-Sutured Tendon

Suture, Nonabsorbable, Synthetic, Polyethylene

Mericron XL

Braided Coated Poly(Ethylene Terephthalate) White/Green With Ptfe Pledget

Suture, Nonabsorbable, Synthetic, Polyethylene

PowerSuture

Meniscal Needles – Single Armed White – Blue Braided UHMWPE Non-Absorbable Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

BroadBand Loop

6 catalogue numbers from CM-0306CN, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

PowerKnot High Strength Sutures

PowerKnot RDI, #2, black/blue/white w/ needle

Suture, Nonabsorbable, Synthetic, Polyethylene

Syneture

Coated Monofilament Polybutester,CV-Coated Monofilament Polybutester

Suture, Nonabsorbable, Synthetic, Polyethylene

Suture Loop HI-FI

SutureLoop Hi-Fi Suture, 20 inch Loop no. 2 (5 metric) White/Blue, Hi-FI Polyblend Suture, Straight Needle

Suture, Nonabsorbable, Synthetic, Polyethylene

Polyester

6 catalogue numbers from POLYESTER, listed by Resorba Medical GmbH, Germany, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Parcus Suture Tape

Sterile Parcus Suture Tape

Suture, Nonabsorbable, Synthetic, Polyethylene

Powertex

2 catalogue numbers from SUTRPBLAG1, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Mani Sutures Polyester

22 catalogue numbers from 3371, listed by Mani, Inc., United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Permatape™ Suture

1.1mm Suture Tape w/ Double Armed Meniscal Needles Blue, UHMWPE Non-absorbable Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

DeRoyal

Suture Ticron BRD Blue CV-305SZ 2-0 18 IN

Suture, Nonabsorbable, Synthetic, Polyethylene

Maxbraid PE

White/Blue Co-braid Polyethylene Size 2 38" HC-5 Needle Biomet

Suture, Nonabsorbable, Synthetic, Polyethylene

Permatape

PERMATAPE Suture White-Blue Braided Tape OS-6 36mm 1/2c Reverse Cutting 1.3mm 36" (91cm)

Suture, Nonabsorbable, Synthetic, Polyethylene

Fast-FIX

Tfcc Fast-FIX KIT Includes Fast-FIX 360 Delivery Device, Disposable Slotted Cannula, AND Knot Pusher/Suture Cutter

Suture, Nonabsorbable, Synthetic, Polyethylene

Powertex

Powertex White/Black Co-braid Size 2 36" SBM

Suture, Nonabsorbable, Synthetic, Polyethylene

Premipatch

Premipatch 2 Ptfe Soft Pledgets 16X7MM

Suture, Nonabsorbable, Synthetic, Polyethylene

Surgidac

Uncoated Braided Polyester,GS-18,D/A,1x Green Strand

Suture, Nonabsorbable, Synthetic, Polyethylene

Permaloop™ Mini Suture

1.1mm Suture Tape w/ Looped End White/Blue, UHMWPE Non-absorbable Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Unify Polyester Surgical Sutures

UNIFY Polyester Surgical Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18"

Suture, Nonabsorbable, Synthetic, Polyethylene

BroadBand Mini Loop

4 catalogue numbers from CM-0304, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Ultratape 2MM Blue 38 PKG OF 6

Suture, Nonabsorbable, Synthetic, Polyethylene

Suture, Nonabsorbable, Synthetic, Polyethylene

Who Makes This Device Type in China?

How Is GAT Classified?

How Does It Reach the US Market?

What Do the Recalls Say?

Where China Actually Supplies