Duns Number:792528510
Device Description: 5mm 45cm Insulated Stainless Steel Handle & Shaft, Rotatable 1-piece with flush port, for 5mm 45cm Insulated Stainless Steel Handle & Shaft, Rotatable 1-piece with flush port, for use with disposable tips
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5260106
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
ceea7567-ea11-49a7-a1e9-5ebdc38d60d9
Public Version Date
December 07, 2021
Public Version Number
1
DI Record Publish Date
November 29, 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 |