Duns Number:008965063
Device Description: Full Adhesive Heat Wraps Neck, Shoulder & Wrist
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
993095
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
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
OMW
Product Code Name
Adhesive Backed Thermal Skin Patches
Public Device Record Key
3296a4a9-5836-40f1-a86a-cc6855316db3
Public Version Date
June 12, 2020
Public Version Number
1
DI Record Publish Date
June 04, 2020
Package DI Number
10311917194070
Quantity per Package
24
Contains DI Package
00311917194073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |