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
Catalog Number:
Company Name: Foosin Medical Supplies Inc., Ltd.

Primary DI Number: 06941813610540
Issuing Agency: GS1
Device Count: 1

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polydioxanone suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] 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 provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Polydioxanone suture

A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] 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 provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
NEW	Suture, Surgical, Absorbable, Polydioxanone

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

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Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: April 11, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
06941813615545	12	06941813610540		In Commercial Distribution

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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