FDA.reportPublic FDA data

TELEFLEX

Primary DI
04026704735181
Brand
TELEFLEX
Company
TELEFLEX INCORPORATED
Model
IPN056735
Catalog number
72205428
Device description
UHMWPE Size 2 blue braid 1 needle 40" Smith and Nephew
Published
2021-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172016000Force Fiber Fusion SutureTeleflex Medical Incorporated2017-10-03GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704735181PackageGS112In Commercial Distribution
24026704735185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704735181040267047351814026704735181
2402670473518524026704735185

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222951ARROWCV-22703-ECV-22703-E2026-08-19
10801902222968ARROWCV-25703-ECV-25703-E2026-08-19
10801902222975ARROWCV-26702-ECV-26702-E2026-08-19
10801902222876ARROWCV-12122-FCV-12122-F2026-08-18
10801902222906ARROWCV-15122-UFCV-15122-UF2026-08-18
10801902225631ARROWIBAS-45563-CURVIBAS-45563-CURV2026-08-18
10841156108267TRAPLINERIPN91889355672026-08-18
14026704937452WECKEFXCT1EFXCT12026-08-18
14026704937469WECKEFXSP1EFXSP12026-08-18
14026704937476WECKEFX002EFX0022026-08-18
10801902124354ARROWIPN001121AA-006052016-09-16
10801902145496ARROWIPN039727SAC-01618-1A2019-07-29
10801902160734ARROWIPN915294AI-071212019-12-19
10801902161335ARROWIPN915831AI-071342020-01-27
10801902168846ARROWIPN916860CS-24701-E2022-11-29
10801902171402ARROWIPN917137CA-45703-P1A2022-02-16
10801902172508ARROWIPN917417CS-24306-E2022-11-29
10801902180268ARROWIPN917220AI-071212021-08-19
10801902180589ARROWIPN918510CS-12702-E2022-11-29
10801902180756ARROWIPN917232AI-071342021-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031097414MERSILENEETHICON, LLCGAT2026-08-17
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117210FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117234FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117258FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117296FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117333FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117357FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117371FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117432FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117456FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117494FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117517FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117555FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117579FlexiGRAFT®LIFENET HEALTHGAT2015-09-24