Duns Number:004022104
Device Description: INCORPORATE® 17MM X 14MM X 42MM 10° L VBR IMPLANT
Catalog Number
-
Brand Name
INCORPORATE
Version/Model Number
104-2-17144210
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
MQP
Product Code Name
Spinal Vertebral Body Replacement Device
Public Device Record Key
e546d6fc-30e6-4e48-b05b-8ccc48c5a91a
Public Version Date
December 18, 2020
Public Version Number
4
DI Record Publish Date
March 22, 2019
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 | 1993 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3642 |
| U | Unclassified | 15 |