Duns Number:001157841
Device Description: Cold Therapy Packs, 2.0x3.0" gel pack, with Florals
Catalog Number
-
Brand Name
ColdSPOT
Version/Model Number
502
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
70a5ec5f-3991-49ec-b4d2-c303a93d1f76
Public Version Date
July 30, 2019
Public Version Number
1
DI Record Publish Date
July 22, 2019
Package DI Number
20815137021088
Quantity per Package
2
Contains DI Package
00815137021084
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |