Duns Number:876542390
Device Description: 75 mm Cervical Plate Four Level
Catalog Number
-
Brand Name
Envision
Version/Model Number
154-5475
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2016
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
KWQ
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Public Device Record Key
771e1d29-6a77-480d-8180-cda1e42d8b0f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2015
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 | 3694 |
2 | A medical device with a moderate to high risk that requires special controls. | 3650 |