AccessGUDID - DEVICE: BGEcare Non-sterile Gauze Sponge (06972403300947)

GUDID

Device Identifier (DI) Information

Brand Name: BGEcare Non-sterile Gauze Sponge
Version or Model: GS0103030820020NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xuchang Zhende Surgical Dressing Co., Ltd.

Primary DI Number: 06972403300947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 528104096 *Terms of Use

Device Description: BGEcare Non-sterile Gauze Sponge 3''X3'', 8-Ply, 200 pieces/pack, 20 packs/carton box

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):	No
Over the Counter (OTC):	Yes
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?
48133	Woven gauze pad, non-sterile	A non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / Sponge,Nonresorbable For External Use

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: No
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: 374a130d-c7f1-4c99-899e-4fce98f02604
Public Version Date: March 19, 2021
Public Version Number: 1
DI Record Publish Date: March 11, 2021