Duns Number:832696038
Device Description: SHADOW-LINE SPINAL DISTRACTION SCREW STERILE, 14 MM 5 PER BOX (X 5)
Catalog Number
S-0089
Brand Name
V. Mueller
Version/Model Number
S-0089
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
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
6727bf6a-035b-4baa-84a7-ea4395252da8
Public Version Date
April 30, 2019
Public Version Number
2
DI Record Publish Date
September 14, 2018
Package DI Number
20885403004220
Quantity per Package
5
Contains DI Package
10885403004223
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |