Duns Number:942377524
Device Description: Titan™ Humeral Resurfacing ArthroplastyThe Kolbel retractor blade is attached to the frame Titan™ Humeral Resurfacing ArthroplastyThe Kolbel retractor blade is attached to the frame. The retractor is then used to withdraw muscle and tissue for exposure.
Catalog Number
RET-920-60XL
Brand Name
Integra®
Version/Model Number
RET92060XL
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
4d7f7664-2298-4347-b8f9-e1bc89baaf79
Public Version Date
May 10, 2021
Public Version Number
5
DI Record Publish Date
September 29, 2017
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |