FDA.reportPublic FDA data

SILK

Primary DI
00812444021851
Brand
SILK
Company
RIVERPOINT MEDICAL, LLC
Model
S1639
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
10812444021858PackageGS112In Commercial Distribution
00812444021851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081244402185810812444021858
00812444021851008124440218518124440218510812444021851

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
00840277407962JuggerKnotless® Soft Anchor1200039652025-10-13
00840277407979JuggerKnotless® Soft Anchor1200039662025-10-13
00840277407986JuggerKnotless® Soft Anchor1200039672025-10-13
00840277407993JuggerLoop™ Soft Anchor1200039682025-10-13
00840277408006JuggerLoop™ Soft Anchor1200039692025-10-13
00840277408013JuggerLoop™ Soft Anchor1200039702025-10-13
00840277408020JuggerLoop™ Soft Anchor1200039712025-10-13
00840277407955JuggerKnotless Soft Anchor1200039642025-07-29
00840277405012OC JuggerKnotless® Soft Anchor1200039562024-12-19
00840277405029OC JuggerKnotless® Soft Anchor1200039572024-12-19
00840277405036OC JuggerKnotless® Soft Anchor1200039582024-12-19
00840277405043OC JuggerKnotless® Soft Anchor1200039592024-12-19
00840277405050OC JuggerLoop™ Soft Anchor1200039602024-12-19
00840277405067OC JuggerLoop™ Soft Anchor1200039612024-12-19
00840277405074OC JuggerLoop™ Soft Anchor1200039622024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SP1200039632024-12-19
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022124RIVERPOINT BRACHYTHERAPYGM1053-18202015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00381780363883Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGAP2017-01-05
04038653826230SilkamB BRAUN SURGICAL SAGAP2015-11-12
04038653826469SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653826513SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653741502SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741526SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741601SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741700SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741786SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741816SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741830SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741854SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741892SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741915SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742196SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742257SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742271SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742776SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742936SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742950SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742974SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742998SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741243SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741281SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741403SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741441SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741625SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743131SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743438SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743414SilkamB BRAUN SURGICAL SAGAP2015-08-20