Duns Number:832696038
Device Description: MILLIN-BACON RETROPUBIC PROSTATECTOMY RETRACTOR MALLEABLE CENTER BLADE 2 SETS OF SWIVEL BL MILLIN-BACON RETROPUBIC PROSTATECTOMY RETRACTOR MALLEABLE CENTER BLADE 2 SETS OF SWIVEL BLADES
Catalog Number
GU8500
Brand Name
V. Mueller
Version/Model Number
GU8500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2018
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
FFO
Product Code Name
RETRACTOR, SELF-RETAINING
Public Device Record Key
155fc7f1-d186-418a-ba21-76713a67e0cf
Public Version Date
April 08, 2019
Public Version Number
2
DI Record Publish Date
August 30, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |