FDA.report

CytoTex

Primary DI
10810020089087
Brand
CytoTex
Company
RIVERPOINT MEDICAL, LLC
Model
RT-3016
Device description
Suture
Published
2022-04-13
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
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810020089087PackageGS112In Commercial Distribution
00810020089080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008908710810020089087
00810020089080008100200890808100200890800810020089080

GMDN Terms

TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) 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

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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

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