Duns Number:117323785
Device Description: The TITAN CSR® Retractor self-retaining retractor system is a latex-free, reusable system The TITAN CSR® Retractor self-retaining retractor system is a latex-free, reusable system designed to provide access and exposure for surgical procedures.
Catalog Number
TSR106-100
Brand Name
TITAN CSR® Retractor
Version/Model Number
TSR106-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
Yes
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
-
Product Code
FFO
Product Code Name
Retractor, Self-Retaining
Public Device Record Key
6c95fd0c-610e-4be3-88f2-ee984912fc16
Public Version Date
August 04, 2022
Public Version Number
2
DI Record Publish Date
July 26, 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 | 1 |