Duns Number:688817949
Device Description: One person use knee air pad 1ea
Catalog Number
-
Brand Name
CTC-7
Version/Model Number
CTCKFDA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2021
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
43891d85-f321-4e6b-8010-fdd3ddb802f5
Public Version Date
December 07, 2021
Public Version Number
2
DI Record Publish Date
June 15, 2021
Package DI Number
18809315679593
Quantity per Package
5
Contains DI Package
08809315679596
Package Discontinue Date
December 07, 2021
Package Status
Not 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |