AccessGUDID - DEVICE: Equate (00194346066759)

GUDID

Device Identifier (DI) Information

Brand Name: Equate
Version or Model: 4039640
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WAL-MART STORES, INC.

Primary DI Number: 00194346066759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: Equate Super Lice Kit

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

FDA Product Code

[?]

Product Code	Product Code Name
PUN	Lice Removal Kit Containing A Solution

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: e6ef9622-2f44-4fc3-a392-951856f30772
Public Version Date: March 27, 2023
Public Version Number: 1
DI Record Publish Date: March 17, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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