FDA.reportPublic FDA data

SILK

Primary DI
00812444021783
Brand
SILK
Company
RIVERPOINT MEDICAL, LLC
Model
S84
Device description
SUTURE
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812444021780PackageGS112In Commercial Distribution
00812444021783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081244402178010812444021780
00812444021783008124440217838124440217830812444021783

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture"A 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 device(s) [e.g., needle, passer] intended to facilitate suture application. 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."

Regulatory Flags#

DUNS number
964053560
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277412010ApeTapeP63-21B-2040-012026-05-22
00840277412027ApeTapeP63-21W-2040-012026-05-22
00840277404992OsseoFit™ Subscapularis Kit (Suture Anchor)1200020502024-12-31
00840277405005OsseoFit™ Subscapularis Kit (Bone Tunnel)1200020512024-12-31
00840277401380Fracture Repair Suture Kit1100464562022-11-04
00840277401403Open Soft Tissue Repair Suture Kit-Small3910-900-1452022-11-04
00840277401410Open Soft Tissue Repair Suture Kit-Large3910-900-1462022-11-04
00840277401373MaxBraid Suture BroadBand Tape (Basic)1100466022022-07-27
00840277401397MaxBraid Suture BroadBand Tape (Ultra)1100464552022-07-27
00840277411105Native Root500.0002026-05-06
00840277411112Native Root501.0002026-05-06
00840277412034No-Tie Button101.0002026-05-06
00810020082982HS FiberHS2312020-03-04
00810020082999HS FiberHS2322020-03-04
00812444026726HS SUTURE TAPEHS2092017-07-19
00812444026757HS SUTURE TAPEHS2112017-07-19
00810020083491HS FiberHS3392026-04-23
00840277411433SutUpHS156-MU2026-04-14
00840277411440SutUpHS519-MU2026-04-14
00840277411457SutUpHS1062-MU2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028222SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06