Duns Number:315492330
Device Description: tray f cages f cervical spine titanium a Peek
Catalog Number
58.80.50
Brand Name
Medicon
Version/Model Number
58.80.50
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
c59594e0-59b2-451b-aaf3-efe4eaba42e7
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2020
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 | 7911 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1064 |