Duns Number:078572603
Device Description: Perineal Instant Ice Compress with Plastic Cover, 4” x 11”
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS1123
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)
-
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
71977823-e39c-49f7-93f6-17f104c36ae7
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 31, 2021
Package DI Number
10849027005233
Quantity per Package
24
Contains DI Package
00849027005236
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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |