AnchorKnot Suture

GUDID 10685447000430

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

Baylis Médicale Cie Inc

Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament
Primary Device ID10685447000430
NIH Device Record Key3e1a41de-f59a-40b1-a15e-67241693edac
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnchorKnot Suture
Version Model NumberASU-2-0-WB-CL
Company DUNS249225954
Company NameBaylis Médicale Cie Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100685447000433 [Primary]
GS110685447000430 [Package]
Contains: 00685447000433
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-11-30

On-Brand Devices [AnchorKnot Suture]

00685447000501Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diamete
10685447000492Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized d
00685447000488Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except f
10685447000478Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP ex
00685447000464Cartridge, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized di
10685447000454Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized d
00685447000440Cartridge, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP exc
10685447000430Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP ex
00685447000426Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diamete
10685447000416Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized d
00685447000402Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except f
10685447000393Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP ex

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.