Duns Number:039779098
Device Description: A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct acces A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of other orthopaedic instrumentation into the surgical site.
Catalog Number
CTS-001
Brand Name
Soft Tissue Sleeve
Version/Model Number
CTS-001
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
-
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
22589f14-1a72-430a-a0be-295185d48b9e
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |