Duns Number:080935429
Device Description: Hot and Cold Gel Pack,Reusable
Catalog Number
MH76948
Brand Name
Uni-Patch
Version/Model Number
MH76948
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
IME
Product Code Name
Pack, hot or cold, reusable
Public Device Record Key
68f14f53-decc-413e-80b2-feed7191170c
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 30, 2018
Package DI Number
90884527022263
Quantity per Package
48
Contains DI Package
10884527022267
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |