WOODCAST - Casting and splinting product - Dassiet Oy

Duns Number:651254398

Device Description: Casting and splinting product

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More Product Details

Catalog Number

-

Brand Name

WOODCAST

Version/Model Number

C1434S Black

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITG

Product Code Name

Bandage, Cast

Device Record Status

Public Device Record Key

55f7adc3-85c7-4ca3-931f-c4b1c7c66423

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DASSIET OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30