Duns Number:046355210
Device Description: Disposable Monopolar Suction Coagulator with Resectoscope Pin, 8" (20cm) 10 Fr
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
30-5201
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
K895337,K895337,K895337
Product Code
HAM
Product Code Name
Apparatus, Electrosurgical
Public Device Record Key
3d89be3a-f4a6-4deb-b2c1-e00cbe9b9182
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
May 04, 2016
Package DI Number
20841019107403
Quantity per Package
50
Contains DI Package
00841019107409
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 |