Duns Number:969820245
Device Description: The DTRAX® Spinal System is a set of instruments intended and indicated for access and pre The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion.
Catalog Number
DX-22-100
Brand Name
DTRAX® Spinal System
Version/Model Number
DX-22-100
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
K180876,K180876
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
a0b1a72a-e599-4d5d-b787-195186a81dc5
Public Version Date
March 29, 2019
Public Version Number
5
DI Record Publish Date
June 27, 2017
Package DI Number
10852776006086
Quantity per Package
1
Contains DI Package
00852776006089
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |