Duns Number:007138183
Device Description: Cramer Orthogel, Two 1/8" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Cramer Orthogel, Two 1/8" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Biologic
Catalog Number
-
Brand Name
Cramer Orthogel
Version/Model Number
061935
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
ab780ca4-d49d-49d1-b30c-ee095678831c
Public Version Date
November 01, 2018
Public Version Number
1
DI Record Publish Date
October 01, 2018
Package DI Number
10311960620700
Quantity per Package
10
Contains DI Package
00311960620703
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |