Duns Number:046355210
Device Description: Non-Stick Disposable Bipolar Forceps 7 1/2" (19.1cm) Cushing Bayonet, Insulated, 0.7mm Tip
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
19-1200AU
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"
Yes
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
K900533,K900533,K900533
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
a05c58d6-8929-4703-b5ee-b8917e22d7ce
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 25, 2016
Package DI Number
20841019100039
Quantity per Package
25
Contains DI Package
00841019100035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 60 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1505 |
| U | Unclassified | 2 |