AccessGUDID - DEVICE: Avaline Medical NJ LLC (00810077213803)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: SKG x15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SKG x15
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00810077213803
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: Sterile Krinkle Gauze Rolls 15

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?
48127	Woven gauze roll/sheet	A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. 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: 99ba91fd-81ed-4e8f-beae-9701b1b3a354
Public Version Date: April 04, 2023
Public Version Number: 2
DI Record Publish Date: June 17, 2022