KerraCel - CRAWFORD HEALTHCARE LIMITED

Duns Number:543740310

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More Product Details

Catalog Number

CWL1035

Brand Name

KerraCel

Version/Model Number

1 x 18 in

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Device Record Status

Public Device Record Key

65e960fa-6115-4544-968b-5b444fc2d1b5

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

October 01, 2019

Additional Identifiers

Package DI Number

05060077231351

Quantity per Package

5

Contains DI Package

05060077231368

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"CRAWFORD HEALTHCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
U Unclassified 7