AccessGUDID - DEVICE: Avaline Medical NJ LLC (00647679163003)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: CETP18x2.2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CETP18x2.2
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00647679163003
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2022
Device Count: 2
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: 18''x125’ Standard White Crepe Exam Table Paper Pack Of 2

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?
35880	Examination/treatment table paper	A non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	BEDDING, DISPOSABLE, MEDICAL

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: c79dfb6a-c7b6-4aa3-aaa7-5290628fd3e6
Public Version Date: March 16, 2022
Public Version Number: 2
DI Record Publish Date: December 03, 2021