Cravat - CRAVAT1 EA - 37"x 37"x 52" TRIANGULAR BANDAGE, 2 - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: CRAVAT1 EA - 37"x 37"x 52" TRIANGULAR BANDAGE, 2 EA - SAFETY PINS

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More Product Details

Catalog Number

32-600

Brand Name

Cravat

Version/Model Number

07

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ILI

Product Code Name

Sling, Arm

Device Record Status

Public Device Record Key

f331ae0f-d74e-4355-b0dd-24ebcaadd7f5

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48