Duns Number:832637081
Device Description: PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE
Catalog Number
09820065S
Brand Name
ProDisc-C
Version/Model Number
09.820.065S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P070001
Product Code
MJO
Product Code Name
PROSTHESIS, INTERVERTEBRAL DISC
Public Device Record Key
48ae191b-ed5a-4443-b525-8500253920be
Public Version Date
April 21, 2021
Public Version Number
6
DI Record Publish Date
September 08, 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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |