RID - Super Max Sensitive Skin Lice Elimination Kit - Oystershell Consumer Health, Inc

Duns Number:117628199

Device Description: Super Max Sensitive Skin Lice Elimination Kit

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More Product Details

Catalog Number

-

Brand Name

RID

Version/Model Number

02100298/80028

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LJL

Product Code Name

Detectors And Removers, Lice, (Including Combs)

Device Record Status

Public Device Record Key

3301d2a4-60cb-4743-8178-687b381074e8

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OYSTERSHELL CONSUMER HEALTH, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6