AccessGUDID - DEVICE: CVS Health (00050428435953)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health
Version or Model: 310269
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428435953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: No description.

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):	Yes
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?
11719	Finger-stall	A device intended to be worn on an examiner's finger to prevent contamination between patient and examiner. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZB	Finger Cot

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: 9f7fa8aa-9416-4435-9bb4-66d3cf69e449
Public Version Date: December 06, 2021
Public Version Number: 1
DI Record Publish Date: November 26, 2021