Duns Number:023904428
Device Description: COMPRESS, INSTANT COLD GEL PACK 6" x 8"
Catalog Number
-
Brand Name
Cypress
Version/Model Number
97-04
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)
-
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
805fd64d-ff06-4a6b-aa14-676eb8242a39
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 22, 2020
Package DI Number
00815555024155
Quantity per Package
12
Contains DI Package
00815555024148
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 | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |