AccessGUDID - DEVICE: Non-woven 4"x4" 4-ply (00850014433444)

GUDID

Device Identifier (DI) Information

Brand Name: Non-woven 4"x4" 4-ply
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DU1204
Company Name: DISTRIBUTION UNLIMITED, LLC

Primary DI Number: 00850014433444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926603486 *Terms of Use

Device Description: is a sponge for wound dressing, prepping, and scrubbing.

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):	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?
48130	Non-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 non-woven material (e.g., rayon, polyester, cellulose pulp) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. 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
Height: 4 Inch
Length: 4 Inch

Device Record Status

Public Device Record Key: f4bd4bc8-5572-45c2-82d7-31a8a996d6ef
Public Version Date: August 14, 2020
Public Version Number: 1
DI Record Publish Date: August 06, 2020