AccessGUDID - DEVICE: Avaline Medical NJ LLC (00667605030063)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: vdcr100.2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: vdcr100.2
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00667605030063
Issuing Agency: GS1
Commercial Distribution End Date: March 22, 2022
Device Count: 100
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: 100 Dental Cotton Rolls

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?
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFN	COTTON, ROLL

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: 4f6f0aeb-7356-4503-9683-4b4927c54760
Public Version Date: March 23, 2022
Public Version Number: 2
DI Record Publish Date: December 03, 2021