Duns Number:792528510
Device Description: RETRACTION GRASPER 2X3 TEETH DOUBLE ACTION 5mmX32cm SLIDE-LOCK HANDLE ROTATING MODULAR DES RETRACTION GRASPER 2X3 TEETH DOUBLE ACTION 5mmX32cm SLIDE-LOCK HANDLE ROTATING MODULAR DESIGN
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5260534C
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
4985b004-96e7-4c91-bee8-9ced6679e589
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 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 |