Duns Number:830350380
Device Description: CASE 778001109 MRC 4.5 IMPL MOD
Catalog Number
-
Brand Name
CD HORIZON® Spinal System
Version/Model Number
778001109
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
K190840
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
3cc42945-9a9b-4fc7-9b72-ad9a4f7e4849
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
September 19, 2021
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 |