Duns Number:482661753
Device Description: TCK1 HD Camera Head, C-Mount
Catalog Number
242400
Brand Name
NA
Version/Model Number
242400
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 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
FWF
Product Code Name
CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO
Public Device Record Key
c41bd7c3-7bb4-4a13-8452-36ab2225b806
Public Version Date
January 28, 2021
Public Version Number
4
DI Record Publish Date
January 30, 2016
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 | 972 |
2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
3 | A medical device with high risk that requires premarket approval | 20 |
U | Unclassified | 20 |