AccessGUDID - DEVICE: Pro Advantage (M220761002)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Advantage
Version or Model: 76100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76100
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: M220761002
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: PA APPLICATOR COTTON 3 NS WOOD 100/BG 10BG/BX 10BX/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?
64011	General-purpose absorbent tip applicator/swab, reusable	A hand-held manual device in the form of a slender handle made of metal intended to hold an absorbent material such as a cotton pledget at its distal end for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is typically used in a healthcare setting. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXF	Applicator, Absorbent Tipped, Non-Sterile

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: ebeff250-e914-4f69-8a51-62e3287493c7
Public Version Date: September 19, 2025
Public Version Number: 1
DI Record Publish Date: September 11, 2025