AccessGUDID - DEVICE: RID (00810061048145)

GUDID

Device Identifier (DI) Information

Brand Name: RID
Version or Model: 02100297/80014X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oystershell Consumer Health, Inc

Primary DI Number: 00810061048145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117628199 *Terms of Use

Device Description: Super Max Sensitive Skin Lice Elimination 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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
45370	Lice removal/prevention kit	A collection of non-sterile devices intended to physically and chemically remove human head lice (Pediculus humanus capitis) and/or their eggs (nits) from an infested individual, and/or to prevent (re)infestation. It includes a lice removal and/or prevention agent(s) [e.g., shampoo, solution, emulsion] and also includes additional devices, typically one or more of the following: manual lice comb, shower cap, laundry additive. It does not include lice vacuuming devices. It is normally available [non-prescription] 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: 731e5df6-f915-4733-b47d-fe2cf023277e
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 23, 2022

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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