AccessGUDID - DEVICE: Avaline Medical NJ LLC (00650415208913)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: NAP3X4X200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NAP3X4X200
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00650415208913
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2022
Device Count: 200
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: 3x4 Non-Adherent Pads 100x2

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?
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) 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; in some cases, the device’s packaging may be used as a disposable tray. 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: 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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a4f411e-3098-4b00-860f-7d219bc16ca2
Public Version Date: November 07, 2024
Public Version Number: 3
DI Record Publish Date: November 21, 2022