Duns Number:832696038
Device Description: OBERHILL LAMINECTOMY RETRACTOR 4 PRONG BLADES 25 X 25MM WIDE SELF-RETAIN, W/RATCHET CATCH OBERHILL LAMINECTOMY RETRACTOR 4 PRONG BLADES 25 X 25MM WIDE SELF-RETAIN, W/RATCHET CATCH OVERALL LENGTH 12-1/4"(31.1CM)
Catalog Number
NL5412
Brand Name
V. Mueller
Version/Model Number
NL5412
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
GZT
Product Code Name
RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
Public Device Record Key
54ef5580-0c28-4ca8-aae8-24dc2672a752
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
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 |