Duns Number:486711679
Device Description: 3.7MM TI CERV SPN SCR SLF-TPNG VARIABLE ANGLE 18MM-STERILE
Catalog Number
04647878S
Brand Name
NA
Version/Model Number
04.647.878S
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
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
K121852
Product Code
OVE
Product Code Name
Intervertebral fusion device with integrated fixation, cervical
Public Device Record Key
1ab50778-97ff-4f6e-b73f-a0989a12edfa
Public Version Date
April 26, 2022
Public Version Number
4
DI Record Publish Date
September 14, 2015
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |