KerraFoam Gentle Border - CRAWFORD HEALTHCARE LIMITED

Duns Number:543740310

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More Product Details

Catalog Number

CWL1132

Brand Name

KerraFoam Gentle Border

Version/Model Number

6 x 6in

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

6e20dffa-abd4-42e5-bb3d-21bc5d834d93

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

October 01, 2019

Additional Identifiers

Package DI Number

05060077232488

Quantity per Package

4

Contains DI Package

05060077232471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"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