Duns Number:152793493
Device Description: Hydrocolloid Gel Blister Cushions, assorted sizes (42 mm x 68 mm; 34 mm x 54 mm; 17 mm x 5 Hydrocolloid Gel Blister Cushions, assorted sizes (42 mm x 68 mm; 34 mm x 54 mm; 17 mm x 59 mm)
Catalog Number
017276233940
Brand Name
ALL-HEALTH Hydrocolloid Gel Cushions
Version/Model Number
017276233940
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 19, 2021
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"
Yes
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
1a24afcb-c699-4f34-aec3-7067b49417c3
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
March 29, 2019
Package DI Number
20017276233944
Quantity per Package
72
Contains DI Package
00017276233940
Package Discontinue Date
January 19, 2021
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |