Duns Number:792528510
Device Description: 3mm 20cm Atraumatic Fenestrated Grasper, cuved 16mm double action jaw, insulated shaft & t 3mm 20cm Atraumatic Fenestrated Grasper, cuved 16mm double action jaw, insulated shaft & type 18 handle: carbon-fiber with RF post, ratchet/ratchet defeating
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5302037B18
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
429a6345-cba8-4d92-beba-48dddec29eba
Public Version Date
July 06, 2021
Public Version Number
1
DI Record Publish Date
June 28, 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 |