Duns Number:792528510
Device Description: Power Grip Bipolar 5mm 45cm Marylard Forceps complete handle insert shaft modular 3 piece Power Grip Bipolar 5mm 45cm Marylard Forceps complete handle insert shaft modular 3 piece take apart
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-52215516
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"
-
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
-
Product Code
HIN
Product Code Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Public Device Record Key
72f8d1f9-0c23-4617-9168-f44975576f32
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6832 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9482 |