FDA.reportPublic FDA data

Riversilk

Primary DI
00840277405487
Brand
Riversilk
Company
RIVERPOINT MEDICAL, LLC
Model
S733
Device description
Suture
Published
2025-01-14
Public version status
New
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
10840277405484PackageGS112In Commercial Distribution
00840277405487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084027740548410840277405484
00840277405487008402774054878402774054870840277405487

GMDN Terms#

Term, Definition table
TermDefinition
Silk sutureA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022124RIVERPOINT BRACHYTHERAPYGM1053-18202015-10-22
00812444022162RIVERPOINT BRACHYTHERAPYGM1233-17202015-10-22
00812444022216RIVERPOINT BRACHYTHERAPYGM1253-17202015-10-22
00812444022223GOLD MARKER NEEDLEGM1251-17202015-10-23
00812444022230GOLD MARKER NEEDLEGM0833-18202015-10-24
00812444022919RIVERPOINT BRACHYTHERAPYGM0853-18202015-10-24
00812444023183RIVERPOINT BRACHYTHERAPYGM0833K-18202015-10-22
00812444023237FIDUCIAL NEEDLESFN17-532015-10-24
00812444023244FIDUCIAL NEEDLESFN17-312015-10-24
00812444023299FIDUCIAL NEEDLESFN18-12015-10-24
00812444023305FIDUCIAL NEEDLESFN17-32015-10-24
00812444023312FIDUCIAL NEEDLESFN18-32015-10-24
00812444023411RIVERPOINT BRACHYTHERAPYGM0851-18202015-10-24
00812444023428RIVERPOINT BRACHYTHERAPYGM0851K-18202015-10-24
00812444023435RIVERPOINT BRACHYTHERAPYGM0831K-18202015-10-24
00812444023442RIVERPOINT BRACHYTHERAPYGM0853K-18202015-10-24
00812444023466RIVERPOINT BRACHYTHERAPYGM0851-SS25-18202015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837402363TRUSILKHEALTHIUM MEDTECH LIMITEDGAP2026-08-19
08903837402387TRUSILKHEALTHIUM MEDTECH LIMITEDGAP2026-08-19
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