KOSMA-KARE - COTTON COIL 12 G/Y - 18LBS /CS - Kosma-Kare Canada Inc

Duns Number:248955460

Device Description: COTTON COIL 12 G/Y - 18LBS /CS

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More Product Details

Catalog Number

-

Brand Name

KOSMA-KARE

Version/Model Number

KC-2292

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

FRL

Product Code Name

Fiber, Medical, Absorbent

Device Record Status

Public Device Record Key

8ca0e828-40a8-45af-b171-76b1a262e7f0

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

October 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOSMA-KARE CANADA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35