Duns Number:832696038
Device Description: SHADOW-LINE SPINAL DISTRACTION SCREWDRIVER FOR USE W / DISTRACTION SCREWS S-0088 THRU S-00 SHADOW-LINE SPINAL DISTRACTION SCREWDRIVER FOR USE W / DISTRACTION SCREWS S-0088 THRU S-0098
Catalog Number
S-1306
Brand Name
V. Mueller
Version/Model Number
S-1306
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
f5eb4e5a-0b82-4559-96cf-59f89d7036e0
Public Version Date
October 15, 2018
Public Version Number
1
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 |