Duns Number:279456896
Device Description: This reusable Hot & Cold therapy pack helps patients manage pain and swelling following im This reusable Hot & Cold therapy pack helps patients manage pain and swelling following implantology procedures.- Sized 10 x 11.5 cm, it offers full coverage of the surgical area.- Easy to store and use: Simply store in a freezer until ready to use- Comfortable thanks to its non-woven cover- To administer heat: simply place in the microwave for twice 15 seconds to heat up
Catalog Number
HY-301
Brand Name
HYGITECH
Version/Model Number
HY-301
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMD
Product Code Name
Pack, Hot Or Cold, Disposable
Public Device Record Key
cd7f0e05-b71f-45fb-bb01-0710e7a4adbd
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140000437
Quantity per Package
1
Contains DI Package
03615140000420
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |