Duns Number:969820245
Device Description: A set of individual non-powered, disposable, hand-held surgical instruments intended and i A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver.
Catalog Number
DX-22-600
Brand Name
DTRAX® Spinal System-L
Version/Model Number
DX-22-600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
f78fb550-ed1f-4522-a5d7-ff1ee90af710
Public Version Date
June 07, 2019
Public Version Number
5
DI Record Publish Date
October 12, 2016
Package DI Number
10852776006185
Quantity per Package
1
Contains DI Package
00852776006188
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 |