Duns Number:830350380
Device Description: TRAY 7068037 5.5/6.0 SPACE-D TLIF TRAY
Catalog Number
-
Brand Name
Space-D™ System 5.5/6.0 Voyager Instrument Set
Version/Model Number
7068037
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
cd630dab-8279-4741-85e5-46150986dd6d
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
March 12, 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 |