FDA.report

DEKNATEL

Primary DI
34026704424338
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN025493
Catalog number
S-924
Device description
RC SLK BK BR 2-0 24"X12
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAPSUTURE, NONABSORBABLE, SILK

Product Code Classifications

CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704424338PackageGS136In Commercial Distribution
04026704424337PreviousGS10
14026704424334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670442433834026704424338
04026704424337040267044243374026704424337
1402670442433414026704424334

GMDN Terms

TermDefinition
Silk suture, sterileA sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Device Sizes

TypeValueUnit
Length24Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
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
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

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20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10841336117645Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117898Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
00841336117907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117911Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117928Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117935Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117942Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117959Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
00840277410153SilkRIVERPOINT MEDICAL, LLCGAP2025-07-29
10814639026747Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026754Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026761Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026778Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026785Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026792Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10840277408577SilkRIVERPOINT MEDICAL, LLCGAP2025-06-18
10840277408591RiversilkRIVERPOINT MEDICAL, LLCGAP2025-06-18
10848782052025OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052032OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052049OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052056OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052063OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052070OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052278OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10840277409192SilkRIVERPOINT MEDICAL, LLCGAP2025-03-13
10840277409208SilkRIVERPOINT MEDICAL, LLCGAP2025-03-13
10840277408560SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408584RiversilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408843SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408850SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28