Duns Number:051957769
Device Description: Hydrocolloid Gel Blister Cushions, one size, 1.65 IN x 2.67 IN (42 mm x 68 mm)
Catalog Number
-
Brand Name
Ozark Trail Outdoor Equipment
Version/Model Number
017276235937
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
199fcdb1-3cf7-4a86-9b8b-740d7a75c298
Public Version Date
June 03, 2020
Public Version Number
2
DI Record Publish Date
February 28, 2020
Package DI Number
20017276235931
Quantity per Package
12
Contains DI Package
00017276235937
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |