Duns Number:965399905
Catalog Number
-
Brand Name
Clear Guide TipTAG
Version/Model Number
CGTT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JAC
Product Code Name
System, X-Ray, Film Marking, Radiographic
Public Device Record Key
40bbefbb-6388-4fc4-9a01-2a5614400d52
Public Version Date
October 07, 2022
Public Version Number
3
DI Record Publish Date
April 07, 2017
Package DI Number
B201CGTT1
Quantity per Package
10
Contains DI Package
B201CGTT0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |