Duns Number:830350380
Device Description: PUNCH 6972487 RAIL
Catalog Number
-
Brand Name
PRESTIGE® LP Cervical Disc System
Version/Model Number
6972487
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
P090029
Product Code
MJO
Product Code Name
PROSTHESIS, INTERVERTEBRAL DISC
Public Device Record Key
65f366ec-561f-455e-a095-3445fab0d274
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2014
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |