Duns Number:071595540
Device Description: DETACHATIP III SHAFT, MULTIPLE USE SCISSORS, CURVED MINI-METZENBAUM
Catalog Number
3-4304
Brand Name
DETACHATIP
Version/Model Number
3-4304
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 2018
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
K123260
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
7dcc1918-731a-4e56-9d09-986af43088ef
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 03, 2017
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |