FDA.report

SharpShooter

Primary DI
00810020080087
Brand
SharpShooter
Company
RIVERPOINT MEDICAL, LLC
Model
PB4704S
Device description
Suture
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GASSuture, Nonabsorbable, Synthetic, Polyester

Product Code Classifications

CodeDeviceSpecialtyClass
GASSuture, Nonabsorbable, Synthetic, PolyesterGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810020080087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810020080087008100200800878100200800870810020080087

GMDN Terms

TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
964053560
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

Primary DIBrandModelCatalogPublished
00840277405609LigaMend™ (Black)102.0002026-03-19
00840277405616LigaMend™ (Blue)112.0002026-03-19
00840277405623LigaMend™105.0002026-03-19
00840277405630Strut Suture103.0002026-03-19
00840277405715LigaMend™ Soft Button (Black)106.0002026-03-19
00840277405722LigaMend™ Soft Button (Blue)116.0002026-03-19
00840277411358No-Tie Button111.0002026-03-19
10810020085218HS FiberHS1652026-03-16
10840277411768HS FiberHS2412026-03-16
10840277411775HS FiberHS2422026-03-16
10840277411782HS FiberHS2432026-03-16
10840277411799HS FiberHS2442026-03-16
00840277411808HS FiberHS2452026-03-16
10840277411812Gold MarkerGM0453-20202026-03-11
00812444029673OrthoButton ALOBAL802026-03-03
00840277411068HS FiberDFX00182026-01-26
00840277411396HS FiberHS9032026-01-13
10840277411409HS FiberHS9042026-01-13
00840277410023ProZip Knotless ImplantCAT105012026-01-06
00840277410030ProZip Knotless ImplantCAT105022026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840124514126TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124514188TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124524774TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124521339TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521346TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521353TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521360TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
10850012846540RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
10840277408386PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408393PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408409PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408416PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408423RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408430RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408447RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408454RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409130PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409147PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409413RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409437RiverBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840124513044TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513051TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513068TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513075TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513082TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513099TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513105TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513112TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513129TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22
00840124513136TopLockFUSION ORTHOPEDICS, LLCGAS2024-07-22