Duns Number:332893028
Device Description: Acoustic neuroma ring-forceps, 70°-80°curved upw, bipolar angled, very fine, ring-ø AD 1.0 Acoustic neuroma ring-forceps, 70°-80°curved upw, bipolar angled, very fine, ring-ø AD 1.0, 16 cm
Catalog Number
80-202-01
Brand Name
Bipolar Forceps
Version/Model Number
80-202-01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101080
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
55a60391-318e-4ae3-a8e6-c95c3e6a25aa
Public Version Date
June 17, 2019
Public Version Number
1
DI Record Publish Date
June 07, 2019
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 | 1960 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |