Duns Number:007928633
Device Description: All Titanium Super-Slide III Retractor Extended Set Consists of the Following: 1x 7329-10m All Titanium Super-Slide III Retractor Extended Set Consists of the Following: 1x 7329-10m, 4x 7329-82m, 4x 7329-84m, 4x 7329-86m and 4x 7329-87m 2x 7329-60m 2x 7329-62m 2x 7329-68m 1x 7329-90m
Catalog Number
7329-05M
Brand Name
All Titanium Super Slide III Self Retaining Retractor, Extended Set
Version/Model Number
7329-05M
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
5f2ce0b9-4e74-4a0a-9006-df1e48a9dc64
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 |