FDA.reportPublic FDA data

Biotex

Primary DI
08800039003308
Brand
Biotex
Company
PURGO BIOLOGICS Inc.
Model
BT501655
Published
2020-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180992000BiotexPurgo Biologics, Inc.2019-07-16NBY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039003308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039003308088000390033088800039003308

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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687429456
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039000123THE GraftTG-AS252018-10-15
08800039000130THE GraftTG-AS052018-10-15
08800039000147THE GraftTG-AS102018-10-15
08800039000277THE GraftTG-BS252018-10-15
08800039000284THE GraftTG-BS052018-10-15
08800039000291THE GraftTG-BS102018-10-15
08800039006651TBS PTFE SuturePTFE3022 2025-07-24
08800039006668TBS PTFE SuturePTFE4022 2025-07-24
08800039006675TBS PTFE SuturePTFE5022 2025-07-24
08800039006682TBS PTFE membraneTBSRGN082025-07-24
08800039006354BiotexBT3019D2025-04-24
08800039006361BiotexBT4019D2025-04-24
08800039006378BiotexBT5019D2025-04-24
08800039006385BiotexBT3016D2025-04-24
08800039006392BiotexBT4016D2025-04-24
08800039006408BiotexBT5016D2025-04-24
08800039006415BiotexBT3013D2025-04-24
08800039006422BiotexBT4013D2025-04-24
08800039006439BiotexBT5013D2025-04-24
08800039006446BiotexBT301935D2025-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10652927432357Demetech PTFEDemetech CorporationNBY2019-07-11
10652927432364Demetech PTFEDemetech CorporationNBY2019-07-11
10652927668039Demetech PTFEDemetech CorporationNBY2019-07-10
10652927670148Demetech PTFEDemetech CorporationNBY2019-07-10
10652927670179Demetech PTFEDemetech CorporationNBY2019-07-10