Duns Number:007928633
Device Description: Super-Slide II Ti Blade Small 1-1/2"
Catalog Number
7329-16T
Brand Name
Super-Slide Ti Blade Small
Version/Model Number
7329-16T
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
K881160,K881160
Product Code
GZT
Product Code Name
Retractor, Self-Retaining, For Neurosurgery
Public Device Record Key
f1cb88f4-feba-4cfc-ab2f-6957d4a4e127
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 01, 2022
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 | 2597 |
2 | A medical device with a moderate to high risk that requires special controls. | 416 |