Duns Number:119193803
Device Description: Replacement Tips for the GP Cut Gutta Percha Cutter
Catalog Number
71-36211 M
Brand Name
GP Cut Replacement Tip Medium
Version/Model Number
7136211 M
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
Yes
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
EKD
Product Code Name
Instrument, Cutting, Operative
Public Device Record Key
9c9d27ee-918a-4c04-891f-46737e5af347
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
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 | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |