Duns Number:315018218
Device Description: MODULIFT VBR SZ.L 23.5-30.5MM POST.9°KYP
Catalog Number
MF789T
Brand Name
MODULIFT
Version/Model Number
MF789T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2020
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
MQP
Product Code Name
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Public Device Record Key
254194d7-3449-491f-8472-7d1695f201fd
Public Version Date
July 30, 2020
Public Version Number
4
DI Record Publish Date
January 20, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |