Catalog Number

-

Brand Name

Cramer Orthogel

Version/Model Number

061925

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

fbd24bf0-1c6a-4de7-b45b-8aec6eef5d60

Public Version Date

April 16, 2019

Public Version Number

1

DI Record Publish Date

April 08, 2019

Package DI Number

10311960619483

Quantity per Package

9

Contains DI Package

00311960619486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master