FDA.reportPublic FDA data

MONOTEX

Primary DI
00812444020519
Brand
MONOTEX
Company
RIVERPOINT MEDICAL, LLC
Model
T8000
Device description
SUTURE
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10812444020516PackageGS112In Commercial Distribution
00812444020519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081244402051610812444020516
00812444020519008124440205198124440205190812444020519

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
964053560
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277407962JuggerKnotless® Soft Anchor1200039652025-10-13
00840277407979JuggerKnotless® Soft Anchor1200039662025-10-13
00840277407986JuggerKnotless® Soft Anchor1200039672025-10-13
00840277407993JuggerLoop™ Soft Anchor1200039682025-10-13
00840277408006JuggerLoop™ Soft Anchor1200039692025-10-13
00840277408013JuggerLoop™ Soft Anchor1200039702025-10-13
00840277408020JuggerLoop™ Soft Anchor1200039712025-10-13
00840277407955JuggerKnotless Soft Anchor1200039642025-07-29
00840277405012OC JuggerKnotless® Soft Anchor1200039562024-12-19
00840277405029OC JuggerKnotless® Soft Anchor1200039572024-12-19
00840277405036OC JuggerKnotless® Soft Anchor1200039582024-12-19
00840277405043OC JuggerKnotless® Soft Anchor1200039592024-12-19
00840277405050OC JuggerLoop™ Soft Anchor1200039602024-12-19
00840277405067OC JuggerLoop™ Soft Anchor1200039612024-12-19
00840277405074OC JuggerLoop™ Soft Anchor1200039622024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SP1200039632024-12-19
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022124RIVERPOINT BRACHYTHERAPYGM1053-18202015-10-22

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