AccessGUDID - DEVICE: CVS HEALTH (00050428437407)

GUDID

Device Identifier (DI) Information

Brand Name: CVS HEALTH
Version or Model: 168534_400902CV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428437407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: 2-IN-1 LICE REMOVAL COMB

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
17552	Lice comb, manual	A hand-held manual device with specially-designed teeth (tines) spaced with precision and intended to be systematically drawn through the hair, typically following the contour of the scalp, to expose and remove human head lice (Pediculus humanus capitis) and their eggs (nits) from the hair and scalp of an infested person. It is normally available non-prescription and over-the-counter (OTC). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJL	Detectors And Removers, Lice, (Including Combs)

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: f15e85cd-1cd5-4856-a740-77e308ade844
Public Version Date: August 06, 2020
Public Version Number: 1
DI Record Publish Date: July 29, 2020