Duns Number:021056726
Device Description: Disposable Spetzler™-Malis® Dual Irrigating Bipolar Forceps, Bayonet, 7" (18cm), 1.0mm Tip Disposable Spetzler™-Malis® Dual Irrigating Bipolar Forceps, Bayonet, 7" (18cm), 1.0mm Tip, Insulated, Non-Stick
Catalog Number
80-7601
Brand Name
Codman
Version/Model Number
80-7601
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
0a646ab2-da56-4f0b-8c96-091e7902cdb3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 18, 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 | 336 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |