Rael - Mini - CASCO BAY MOLDING LTD.

Duns Number:604286695

Device Description: Mini

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More Product Details

Catalog Number

810027131515

Brand Name

Rael

Version/Model Number

RAEL-CUP-MINI-V10-01

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HHE

Product Code Name

Cup, Menstrual

Device Record Status

Public Device Record Key

f50e813f-83d1-4fe2-bd3c-425b86bb1bd6

Public Version Date

October 09, 2020

Public Version Number

2

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CASCO BAY MOLDING LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 65