Duns Number:965627297
Device Description: Cervical Trial Sizer, 12AP X 14ML X 07HT
Catalog Number
100034-12147
Brand Name
Cervical Cage
Version/Model Number
100034-12147
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 10, 2017
Issuing Agency
In HIBCC
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
13393f58-8142-4f98-9de8-5b8202e6ce8c
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
April 06, 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. | 459 |