Duns Number:146060863
Device Description: Trial, Size 13x16x18mm/14x18x18mm
Catalog Number
7501-90037
Brand Name
CAPRI™ Corpectomy Cage System
Version/Model Number
7501-90037
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
MQP
Product Code Name
Spinal vertebral body replacement device
Public Device Record Key
38bdb561-eaa0-4e53-b562-2e9232a18582
Public Version Date
November 14, 2019
Public Version Number
1
DI Record Publish Date
November 06, 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 | 5699 |
2 | A medical device with a moderate to high risk that requires special controls. | 17961 |