AccessGUDID - DEVICE: Pro Advantage (M220P1571173)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Advantage
Version or Model: P157117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P157117
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: M220P1571173
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: PA GAUZE SPONGE 4X4 8PLY NS 200/SLV 20SLV/CS - (CS)

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":	No
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?
48134	Woven gauze pad	A non-medicated 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: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.	Active	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: 7eb53209-a544-4561-b317-02db2ee3a004
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022