Duns Number:009915751
Device Description: CVBR LCM 23.25 MM
Catalog Number
LCM 23.25 MM
Brand Name
Palo Alto ™
Version/Model Number
LCM 23.25 MM
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PLR
Product Code Name
Spinal vertebral body replacement device - Cervical
Public Device Record Key
3473709a-aac5-42fc-9e8e-87623de4c9e2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 20, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |