FDA.reportPublic FDA data

Vilet

Primary DI
00810020087734
Brand
Vilet
Company
RIVERPOINT MEDICAL, LLC
Model
V301U
Device description
Suture
Published
2022-12-30
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
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120556000VILET VILET QUICKRiverpoint Medical2012-05-23GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810020087731PackageGS112In Commercial Distribution
00810020087734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008773110810020087731
00810020087734008100200877348100200877340810020087734

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

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
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
10884521839830TrexonCovidien LPGAM2026-10-10
10884521839861TrexonCovidien LPGAM2026-10-10
10884521840089TrexonCovidien LPGAM2026-10-10
10884521840126TrexonCovidien LPGAM2026-10-10
10884521840140TrexonCovidien LPGAM2026-10-10
10884521840171TrexonCovidien LPGAM2026-10-10
10884521840195TrexonCovidien LPGAM2026-10-10
10884521840249TrexonCovidien LPGAM2026-10-10
10884521840263TrexonCovidien LPGAM2026-10-10
10884521840270TrexonCovidien LPGAM2026-10-10
10884521840379TrexonCovidien LPGAM2026-10-10
10884521840409TrexonCovidien LPGAM2026-10-10
10884521840430TrexonCovidien LPGAM2026-10-10
10884521840447TrexonCovidien LPGAM2026-10-10
10884521840454TrexonCovidien LPGAM2026-10-10
10884521840461TrexonCovidien LPGAM2026-10-10
10884521840478TrexonCovidien LPGAM2026-10-10
10884521840485TrexonCovidien LPGAM2026-10-10
10884521840492TrexonCovidien LPGAM2026-10-10
10884521840508TrexonCovidien LPGAM2026-10-10
10884521840591TrexonCovidien LPGAM2026-10-10
10884521840614TrexonCovidien LPGAM2026-10-10
10884521840645TrexonCovidien LPGAM2026-10-10
10884521840652TrexonCovidien LPGAM2026-10-10
10884521840669TrexonCovidien LPGAM2026-10-10
10884521840676TrexonCovidien LPGAM2026-10-10
10884521840683TrexonCovidien LPGAM2026-10-10
10884521840690TrexonCovidien LPGAM2026-10-10
10884521840706TrexonCovidien LPGAM2026-10-10
10884521840720TrexonCovidien LPGAM2026-10-10