Duns Number:046355210
Device Description: Disposable Cautery Variable High Temperature, Fine Tip
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
41-6145
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
K062659,K062659,K062659
Product Code
HQP
Product Code Name
Unit, Cautery, Thermal, Battery-Powered
Public Device Record Key
e4e18b2c-1422-4700-a5bb-ef0a0113bd23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 08, 2016
Package DI Number
20841019107809
Quantity per Package
50
Contains DI Package
00841019107805
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 |