Duns Number:078719435
Device Description: ComfortGel HydroGel Pads (STL)
Catalog Number
17261M
Brand Name
Ameda, Inc.
Version/Model Number
17261M
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
-
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
MGQ
Product Code Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Public Device Record Key
1b8cbbf9-1a69-4acd-9c5a-0c45830d371e
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
November 18, 2016
Package DI Number
20810725020160
Quantity per Package
24
Contains DI Package
00810725020166
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |