AccessGUDID - DEVICE: Golnit Nylon Monofilament Suture (00850043243038)

GUDID

Device Identifier (DI) Information

Brand Name: Golnit Nylon Monofilament Suture
Version or Model: NB2D3019-75
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Golnit Sutures

Primary DI Number: 00850043243038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 079932697 *Terms of Use

Device Description: Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 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?
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
GAR	Suture, Nonabsorbable, Synthetic, Polyamide

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: 30 Inch
Device Size Text, specify: USP 3/0 Suture Thread
Device Size Text, specify: 19mm 3/8 Circle Reverse Cutting Needle

Device Record Status

Public Device Record Key: e4f6ea00-7cae-4804-bdcc-b117bf7d140a
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: September 17, 2022