Duns Number:942377524
Device Description: Ascension® MCPThe MCP disposable pack for Linvatec/Hall includes a blade and a side burr.
Catalog Number
MCPDISHAL
Brand Name
Ascension®
Version/Model Number
MCP-DIS-HAL
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
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
HTT
Product Code Name
BURR, ORTHOPEDIC
Public Device Record Key
8c7b8c11-25aa-4291-b9cf-6bb406950fbd
Public Version Date
October 12, 2018
Public Version Number
1
DI Record Publish Date
September 11, 2018
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 |