FDA.reportPublic FDA data

Cytoplast™ PTFE Suture

Primary DI
D765CS0518K0
Brand
Cytoplast™ PTFE Suture
Company
Osteogenics Biomedical Inc
Model
CS0518K
Device description
Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, 16 mm 3/8 Circle Precision Reverse Cutting Needle
Published
2017-11-15
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
D765CS0518K0PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length18Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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