Duns Number:688817949
Device Description: Device(Black) 1ea, Reusable knee wrap 1ea, Resuable Universal wrap(M) 1ea, Hose 1ea, Assis Device(Black) 1ea, Reusable knee wrap 1ea, Resuable Universal wrap(M) 1ea, Hose 1ea, Assist band 1ea, Recovery bag 1ea
Catalog Number
-
Brand Name
CTC-7
Version/Model Number
CTC7201-RM
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILO
Product Code Name
Pack, Hot Or Cold, Water Circulating
Public Device Record Key
f1c11eb3-ad91-4b29-8e73-dd45c042ef8f
Public Version Date
June 23, 2021
Public Version Number
1
DI Record Publish Date
June 15, 2021
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |