Duns Number:011642563
Device Description: Blue Titanium Square Grip Handle Bayonet Bipolar Forcep With Stop 7 3/4" (196.85mm) Irriga Blue Titanium Square Grip Handle Bayonet Bipolar Forcep With Stop 7 3/4" (196.85mm) Irrigating And Insulated With A Gold 10mm Area With A 1.5mm High Polished Anti-Stick Tip
Catalog Number
-
Brand Name
Titan
Version/Model Number
283928439080101
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
-
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
K974595
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
0364e230-2163-4a1c-baa7-0f48e201ba2c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 31, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 497 |