FDA.report

HS Fiber

Primary DI
00810020088564
Brand
HS Fiber
Company
RIVERPOINT MEDICAL, LLC
Model
HS222
Device description
Suture Tape
Published
2022-05-20
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications

CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810020088568PackageGS16In Commercial Distribution
00810020088564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081002008856820810020088568
00810020088564008100200885648100200885640810020088564

GMDN Terms

TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) 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
00840277412010ApeTapeP63-21B-2040-012026-05-22
00840277412027ApeTapeP63-21W-2040-012026-05-22
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20612479283385McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283392McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283408McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283415McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285303McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285327McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285341McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285389McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285402McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285426McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285440McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285464McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285488McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285518McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285532McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285563McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285594McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285617McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285631McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285655McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285679McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285693McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
00840277412010ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
00840277412027ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
10810020085218HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411768HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411775HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411782HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411799HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
00840277411808HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16