FDA.reportPublic FDA data

Cytoplast™ PTFE Suture

Primary DI
D765CS0528190
Brand
Cytoplast™ PTFE Suture
Company
Osteogenics Biomedical Inc
Model
CS052819
Device description
Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, 19 mm 3/8 Circle Precision Reverse Cutting Needle
Published
2019-02-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D765CS0528191PackageHIBCC12In Commercial Distribution
D765CS0528190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length28Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
123853058
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D765CS0523BK0Cytoplast™ PTFE SutureCS0523BK2019-02-22
D765RPM200ATCM0RPM™ Reinforced PTFE MeshRPM200ATCM2020-07-27
D765GC3019450X-Gut™ Chromic Gut SutureGC3019452025-09-01
D765GC3019750X-Gut™ Chromic Gut SutureGC3019752025-09-01
D765GC3019P450X-Gut™ Chromic Gut SutureGC3019P452025-09-01
D765GC3019P750X-Gut™ Chromic Gut SutureGC3019P752025-09-01
D765GC4013P450X-Gut™ Chromic Gut SutureGC4013P452025-09-01
D765GC4019450X-Gut™ Chromic Gut SutureGC4019452025-09-01
D765GC4019750X-Gut™ Chromic Gut SutureGC4019752025-09-01
D765GC4019P450X-Gut™ Chromic Gut SutureGC4019P452025-09-01
D765GC5013P450X-Gut™ Chromic Gut SutureGC5013P452025-09-01
D765GC5016P450X-Gut™ Chromic Gut SutureGC5016P452025-09-01
D765GC5019450X-Gut™ Chromic Gut SutureGC5019452025-09-01
D765GP3019450X-Gut™ Plain Gut SutureGP3019452025-09-01
D765GP3019750X-Gut™ Plain Gut SutureGP3019752025-09-01
D765GP3022450X-Gut™ Plain Gut SutureGP3022452025-09-01
D765GP3024750X-Gut™ Plain Gut SutureGP3024752025-09-01
D765GP4019450X-Gut™ Plain Gut SutureGP4019452025-09-01
D765GP4019750X-Gut™ Plain Gut SutureGP4019752025-09-01
D765GC3019451X-Gut™ Chromic Gut SutureGC3019452025-09-01

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