Duns Number:004382282
Device Description: TEBBETTS ELECTROSURGICAL MONO-POLAR INSULATED FORCEP; 10''(25.5CM), HAND SWITCHING
Catalog Number
B65244
Brand Name
Tebbetts Hand-Activated Monopolar Insulated Forcep
Version/Model Number
B65244
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
-
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
K072124
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
d2b5f4f7-dde9-454f-af2b-31d1ecdc0994
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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 | 5533 |
2 | A medical device with a moderate to high risk that requires special controls. | 240 |