Duns Number:079641356
Device Description: Symmetry® Retractor, Meyerding Laminectomy, 25.0 mm X 60.0 mm, 7 in
Catalog Number
24-4560
Brand Name
Symmetry Meyerding
Version/Model Number
24-4560
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
K071771
Product Code
GZT
Product Code Name
Retractor, Self-Retaining, For Neurosurgery
Public Device Record Key
63917f8f-1e47-4d5e-8104-52caf0b8d867
Public Version Date
May 10, 2021
Public Version Number
3
DI Record Publish Date
August 28, 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 | 7981 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3309 |