AccessGUDID - DEVICE: Mentholatum Kids Head Lice Removal Kit (00310742011234)

GUDID

Device Identifier (DI) Information

Brand Name: Mentholatum Kids Head Lice Removal Kit
Version or Model: 1123
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MENTHOLATUM COMPANY, THE

Primary DI Number: 00310742011234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002105757 *Terms of Use

Device Description: One 3.38 FL OZ (100 mL) bottle with one lice 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?
46982	Lice treatment solution, synthetic	A non-sterile, liquid substance intended to be applied topically to the scalp and head hair to eradicate human head lice (Pediculus humanus capitis) through physical means. It contains synthetic compound agents (e.g., dimeticone, cyclomethicone, isopropyl myristate) that kill the lice through a non-poisonous action such as: 1) coating and encapsulating the lice preventing the excretion of water that will eventually smother them; or 2) coating them and causing them to dehydrate (loose water) and die; it may also penetrate the lice eggs in order to kill them. It does not include a lice comb. After application, this device cannot be reused.	Active	false
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: 6c064ea9-bee9-4353-bf71-0a77ffd4e2d7
Public Version Date: July 09, 2021
Public Version Number: 1
DI Record Publish Date: July 01, 2021