Duns Number:832696038
Device Description: SHADOW-LINE SPINAL DISTRACTION TWIST DRILL 1.7MM, FOR USE W/ DISTRACTION SCREWS S-0088 THR SHADOW-LINE SPINAL DISTRACTION TWIST DRILL 1.7MM, FOR USE W/ DISTRACTION SCREWS S-0088 THRU S-0098
Catalog Number
S-0107
Brand Name
V. Mueller
Version/Model Number
S-0107
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
0617e2da-96f5-4be9-9155-c2f4bf76df51
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
September 14, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |