Duns Number:007928633
Device Description: Super-Slide II Basic Retractor Set Consists of the Following: 1x 7329-10, 4x 7329-20, 4x 7 Super-Slide II Basic Retractor Set Consists of the Following: 1x 7329-10, 4x 7329-20, 4x 7329-30, 4x 7329-40 and 1x 7329-50
Catalog Number
7329-00
Brand Name
Super Slide II Self Retaining Retractor, Basic Set
Version/Model Number
7329-00
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
Product Code
GZT
Product Code Name
Retractor, Self-Retaining, For Neurosurgery
Public Device Record Key
733f7c34-76b0-4e87-b396-8b374aab1ce0
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
February 28, 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 | 2597 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |