Duns Number:006959555
Device Description: 7.5" x 4.5" (19.1 cm x 11.4 cm) pack with elastic strap that is reusable and relieves sore 7.5" x 4.5" (19.1 cm x 11.4 cm) pack with elastic strap that is reusable and relieves sore muscles, sprains, and swelling.
Catalog Number
-
Brand Name
Meijer Hot & Cold Beads Compress with Strap
Version/Model Number
3458397
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
-
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, Reuseable
Public Device Record Key
91271c18-6615-41e0-a674-0b4cfb01bb96
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |