AccessGUDID - DEVICE: WEGO-PDO Absorbable Surgical Suture With Needle (06941813610540)

GUDID

Device Identifier (DI) Information

Brand Name: WEGO-PDO Absorbable Surgical Suture With Needle
Version or Model: D23353
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Foosin Medical Supplies Inc., Ltd.

Primary DI Number: 06941813610540
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 528180159 *Terms of Use

Device Description: No description.

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":	Yes
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?
16584	Polyester suture, bioabsorbable, monofilament, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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
NEW	Suture, Surgical, Absorbable, Polydioxanone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073614	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e5605d0-d041-4362-bb3e-28b2463c8d32
Public Version Date: July 26, 2021
Public Version Number: 7
DI Record Publish Date: April 11, 2016