FDA.report

PTFE

Primary DI
00812444025934
Brand
PTFE
Company
RIVERPOINT MEDICAL, LLC
Model
5067-643
Device description
Suture
Published
2016-09-29
Public version status
Update
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
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product Code Classifications

CodeDeviceSpecialtyClass
NBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10812444025931PackageGS112In Commercial Distribution
00812444025934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081244402593110812444025931
00812444025934008124440259348124440259340812444025934

GMDN Terms

TermDefinition
Polytetrafluoroethylene sutureA sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of expanded polytetrafluoroethylene (ePTFE) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread, used most frequently in cardiovascular surgery, provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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
false
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
00850061177001DuraStatDurastat LLCNBY2026-03-04
00850061177018DuraStatDurastat LLCNBY2026-03-04
00850061177032DuraStatDurastat LLCNBY2026-03-04
00850061177117DuraStatDurastat LLCNBY2026-03-04
08800039006651TBS PTFE SuturePURGO BIOLOGICS Inc.NBY2025-07-24
08800039006668TBS PTFE SuturePURGO BIOLOGICS Inc.NBY2025-07-24
08800039006675TBS PTFE SuturePURGO BIOLOGICS Inc.NBY2025-07-24
08800039006354BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006361BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006378BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006385BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006392BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006408BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006415BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006422BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006439BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006446BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006453BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006460BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006477BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006484BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006491BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006507BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006514BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006521BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006538BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006545BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006552BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006569BiotexPURGO BIOLOGICS Inc.NBY2025-04-24
08800039006576BiotexPURGO BIOLOGICS Inc.NBY2025-04-24