AccessGUDID - DEVICE: Avaline Medical NJ LLC (00810077214800)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: LGCBx4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LGCBx4
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00810077214800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4000
Labeler D-U-N-S® Number*: 079767953 *Terms of Use
Previous DI: 00667605029043

Device Description: Cotton Balls Large x 4000

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?
63281	Cotton wool ball	A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	FIBER, MEDICAL, ABSORBENT

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: dd170ecb-423d-4a4d-9701-102ec76e4060
Public Version Date: December 08, 2022
Public Version Number: 3
DI Record Publish Date: June 28, 2022