Duns Number:005085972
Device Description: TNCIGFT2 PluggerEnd w/TNCVIPC HatchetEnd
Catalog Number
TNCIGFT2/VIPC
Brand Name
Hu-Friedy
Version/Model Number
TNCIGFT2/VIPC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIY
Product Code Name
INSTRUMENT, FILLING, PLASTIC, DENTAL
Public Device Record Key
1ee14c18-3082-4663-9417-d7a6f00f69f2
Public Version Date
March 03, 2021
Public Version Number
1
DI Record Publish Date
February 23, 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 | 7436 |
2 | A medical device with a moderate to high risk that requires special controls. | 238 |