Duns Number:792528510
Device Description: 10mm 45cm Articulating Fan Retractor, 5 flat, 60deg articulating/folding blades, 90mm max 10mm 45cm Articulating Fan Retractor, 5 flat, 60deg articulating/folding blades, 90mm max width, adjustable handle with flushport, stainless steel
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5251515
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
8f2a24d4-725b-4bbf-af08-e4411ae079a8
Public Version Date
October 01, 2021
Public Version Number
1
DI Record Publish Date
September 23, 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 |