FDA.reportPublic FDA data

DEKNATEL

Primary DI
34026704673170
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN914876
Catalog number
122-R
Device description
READI-CUT SILK BLACK BRAIDED SIZE 2 24 INCHES
Published
2019-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K153089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153089000'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc.2016-08-12GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704673170PackageGS16In Commercial Distribution
14026704673176PrimaryGS10
24026704673173Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670467317034026704673170
1402670467317614026704673176
2402670467317324026704673173

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
38
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
05060112313851LMA AIRWAY MANAGEMENTIPN0478971920302018-09-15
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258654799Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654805Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654812Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654829Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258657141Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665764Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665771Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665795Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665863Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665870Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665894Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665962Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665986Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697864Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697871Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697888Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697895Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697901Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698038Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698045Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698052Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698069Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698076Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698083Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698090Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698106Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698113Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698120Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698137Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698144Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27