Duns Number:152793493
Device Description: Hydrocolloid Gel Blister Cushions, assorted sizes (17 mm x 59 mm; 34 mm x 54 mm; 42 mm x 6 Hydrocolloid Gel Blister Cushions, assorted sizes (17 mm x 59 mm; 34 mm x 54 mm; 42 mm x 68 mm)
Catalog Number
017276233933
Brand Name
ALL-HEALTH Hydrocolloid Gel Cushions
Version/Model Number
017276233933
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"
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
cb79a8c6-6397-4e5a-bf9e-d9d06d4cde4e
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 29, 2019
Package DI Number
20017276233937
Quantity per Package
72
Contains DI Package
00017276233933
Package Discontinue Date
-
Package Status
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 |