Duns Number:615789729
Device Description: MOBI-C IMPLANT M « STANDARD » 19x19 H7 US
Catalog Number
MB3997
Brand Name
Mobi-C
Version/Model Number
MB3997
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
-
Product Code
MJO
Product Code Name
Prosthesis, Intervertebral Disc
Public Device Record Key
182c015b-bb40-4412-a2aa-ace676a89868
Public Version Date
March 10, 2022
Public Version Number
6
DI Record Publish Date
April 12, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2452 |
| 3 | A medical device with high risk that requires premarket approval | 61 |
| U | Unclassified | 40 |