Catalog Number

-

Brand Name

Cramer Blister Derm

Version/Model Number

030905

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

2b2d0038-57a0-404f-bb08-79ea322e27fa

Public Version Date

November 01, 2018

Public Version Number

1

DI Record Publish Date

October 01, 2018

Package DI Number

10311960560617

Quantity per Package

12

Contains DI Package

00311960560610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton