AccessGUDID - DEVICE: Golnit PTFE Suture (00860293000619)

GUDID

Device Identifier (DI) Information

Brand Name: Golnit PTFE Suture
Version or Model: mRD501343-45
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Golnit Sutures

Primary DI Number: 00860293000619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 079932697 *Terms of Use

Device Description: PTFE Non-absorbable Suture 18 Inch in length, USP 5/0, Reverse Cutting Needle, 13mm, 3/8 curvature, Sterile

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
17467	Polytetrafluoroethylene suture	A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of expanded polytetrafluoroethylene (ePTFE) intended to join (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, used most frequently in cardiovascular surgery, provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.	Obsolete	false

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: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 18 Inch
Device Size Text, specify: USP 5/0 Suture Thread
Device Size Text, specify: 13mm 3/8 Circle Reverse Cutting Needle

Device Record Status

Public Device Record Key: 774da996-5d02-4185-81ae-f6c69c6e8beb
Public Version Date: October 10, 2018
Public Version Number: 2
DI Record Publish Date: March 08, 2018