AccessGUDID - DEVICE: Cytoplast™ PTFE Suture (D765CS0518BKSS0)

GUDID

Device Identifier (DI) Information

Brand Name: Cytoplast™ PTFE Suture
Version or Model: CS0518BKSS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osteogenics Biomedical Inc

Primary DI Number: D765CS0518BKSS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123853058 *Terms of Use

Device Description: Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 3-0, Black 16 mm 3/8 Circle Reverse Cutting Needle

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16mm 3/8 Circle RC Needle
Device Size Text, specify: USP 3-0 Suture Rod
Length: 18 Inch

Device Record Status

Public Device Record Key: 2a406a6e-8690-40d9-acf2-756956e27981
Public Version Date: June 02, 2023
Public Version Number: 4
DI Record Publish Date: March 04, 2019