Duns Number:007928633
Device Description: Clearview Super-Slide Retractor Ext Set Consists of the Following: 1x 7329-10T, 4x 7329-20 Clearview Super-Slide Retractor Ext Set Consists of the Following: 1x 7329-10T, 4x 7329-20T, 4x 7329-30T, 4x 7329-40T 4x 7329-47T 6x 7329-48T and 2x 7329-50T 2x 7329-60T 2x 7329-62T 2x 7329-68T 1x 7329-80T
Catalog Number
7329-05T
Brand Name
Clearview Super Slide Lumbar Retractor, Extended Set
Version/Model Number
7329-05T
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
82112f9b-4505-466a-ae4a-f7a1691c760d
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 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 |