FDA.reportPublic FDA data

Cytoplast™ PTFE Suture

Primary DI
D765CS0523BK0
Brand
Cytoplast™ PTFE Suture
Company
Osteogenics Biomedical Inc
Model
CS0523BK
Device description
Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, Black 16 mm 3/8 Circle Reverse Cutting Needle
Published
2019-02-22
Public version status
Update
Distribution status
Not 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
D765CS0523BK1PackageHIBCC12Not in Commercial Distribution
D765CS0523BK0PrimaryHIBCC0

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
Length23Inch

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
D765ZL1000ZCOREZL1002016-04-29
D765ZL2000ZCOREZL2002016-04-29
D765ZS0500ZCOREZS0502016-04-29
D765ZS1000ZCOREZS1002016-04-29
D765ZS2000ZCOREZS2002016-04-29
D765ZS4000ZCOREZS4002016-04-29
D765ZXSOCKET100ZCORE™ EXPANDZXSOCKET-102025-04-14
D765ZXSOCKET50ZCORE™ EXPANDZXSOCKET-52025-04-14
D765ZY0250ZCOREZY0252016-04-29
D765ZY025M20ZCOREZY0252018-12-07
D765ZY0500ZCOREZY0502016-04-29
D765ZY050M20ZCOREZY0502018-12-07
D765ZY1000ZCOREZY1002016-04-29
D765ZXSOCKET10ZCORE™ EXPANDZXSOCKET-12025-04-14
D765ZXSINUSL0ZCORE™ EXPANDZXSINUSL2021-06-25
D765ZXSINUSS0ZCORE™ EXPANDZXSINUSS2021-06-25
D765ZXSOCKET0ZCORE™ EXPANDZXSOCKET2021-06-25
D765ZF0500ZCORE FORMZF0502021-03-12
D765ZF1000ZCORE FORMZF1002021-03-12
D765ZF2000ZCORE FORMZF2002021-03-12

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