Duns Number:792528510
Device Description: 5mm 33cm Fenestrated Grasper, 40mm double action jaw, rotataable 1-piece with flush port, 5mm 33cm Fenestrated Grasper, 40mm double action jaw, rotataable 1-piece with flush port, type 10 handle: lightweight carbon-fiber wit RF post, ratchet/ratchet defeating with large finger loops
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5225540B10
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
07d715e7-aa2f-419b-8fb6-ce2f5f0f4b5d
Public Version Date
November 10, 2021
Public Version Number
1
DI Record Publish Date
November 02, 2021
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 |