FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810020089087PackageGS112In Commercial Distribution
00810020089080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008908710810020089087
00810020089080008100200890808100200890800810020089080

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022124RIVERPOINT BRACHYTHERAPYGM1053-18202015-10-22
00812444022162RIVERPOINT BRACHYTHERAPYGM1233-17202015-10-22
00812444022216RIVERPOINT BRACHYTHERAPYGM1253-17202015-10-22
00812444022223GOLD MARKER NEEDLEGM1251-17202015-10-23
00812444022230GOLD MARKER NEEDLEGM0833-18202015-10-24
00812444022919RIVERPOINT BRACHYTHERAPYGM0853-18202015-10-24
00812444023183RIVERPOINT BRACHYTHERAPYGM0833K-18202015-10-22
00812444023237FIDUCIAL NEEDLESFN17-532015-10-24
00812444023244FIDUCIAL NEEDLESFN17-312015-10-24
00812444023299FIDUCIAL NEEDLESFN18-12015-10-24
00812444023305FIDUCIAL NEEDLESFN17-32015-10-24
00812444023312FIDUCIAL NEEDLESFN18-32015-10-24
00812444023411RIVERPOINT BRACHYTHERAPYGM0851-18202015-10-24
00812444023428RIVERPOINT BRACHYTHERAPYGM0851K-18202015-10-24
00812444023435RIVERPOINT BRACHYTHERAPYGM0831K-18202015-10-24
00812444023442RIVERPOINT BRACHYTHERAPYGM0853K-18202015-10-24
00812444023466RIVERPOINT BRACHYTHERAPYGM0851-SS25-18202015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800039008013TBS PTFE SuturePURGO BIOLOGICS Inc.NBY2026-07-22
08800039008020TBS PTFE SuturePURGO BIOLOGICS Inc.NBY2026-07-22
08800039008037TBS PTFE SuturePURGO BIOLOGICS Inc.NBY2026-07-22
00850043243571Golnit PTFE SutureGolnit SuturesNBY2026-06-08
00850043243618Golnit PTFE SutureGolnit SuturesNBY2026-06-08
08056646500857Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500864Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500871Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500888Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500895Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500901Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500918Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500925Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500932Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500949Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500956Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500963Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509232Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509256Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509270Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509294Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509317Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509331Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509355Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509379Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509393Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509416Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509430Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509454Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
10652927322986Demetech PTFEDemetech CorporationNBY2019-07-11