DEVICE: Cytoplast™ PTFE Suture (D765CS051819BK0)
Device Identifier (DI) Information
Cytoplast™ PTFE Suture
CS051819BK
In Commercial Distribution
Osteogenics Biomedical Inc
CS051819BK
In Commercial Distribution
Osteogenics Biomedical Inc
Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, Black 19 mm 3/8 Circle Reverse Cutting Needle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
13909 | Polyolefin/fluoropolymer suture, monofilament |
A 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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 18 Inch |
Device Size Text, specify: USP 3-0 Suture Rod |
Device Size Text, specify: 19mm 3/8 Circle RC Needle |
Device Record Status
562fd2b4-561a-4ce2-9140-23bb0dea6a16
June 02, 2023
8
July 28, 2017
June 02, 2023
8
July 28, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D765CS051819BK1 | 12 | D765CS051819BK0 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined