Duns Number:079840876
Device Description: Lateral Disc Prep Instrument Tray Level Top
Catalog Number
95-6700-01
Brand Name
Regatta Lateral System
Version/Model Number
95-6700-01
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
-
Product Code
OJH
Product Code Name
Orthopedic tray
Public Device Record Key
4142cf0e-e22e-452e-8684-df8f6c5bd74b
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
September 15, 2018
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 | 5602 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14020 |
| U | Unclassified | 21 |