Duns Number:011642563
Device Description: Scoville-Greenwood Bayonet Bipolar Forcep 7 3/4" (196.85mm) Insulated With A (High Polishe Scoville-Greenwood Bayonet Bipolar Forcep 7 3/4" (196.85mm) Insulated With A (High Polished 10mm Long Area) With A 1.3mm Tip Anti-Stick
Catalog Number
-
Brand Name
Titan
Version/Model Number
162028239070101
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
K974594
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
28293e05-b84b-4a97-a929-aba31a935621
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 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 |