Duns Number:107105876
Device Description: MOSS MIAMI MAGNUM SPINE SYSTEM PEDICLE PROBE,STEFFEE STR. 6.35 30-60mm Plus or Minus 1.33 MOSS MIAMI MAGNUM SPINE SYSTEM PEDICLE PROBE,STEFFEE STR. 6.35 30-60mm Plus or Minus 1.33 Percent
Catalog Number
275010047
Brand Name
MOSS
Version/Model Number
275010047
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2019
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
HXB
Product Code Name
PROBE
Public Device Record Key
c22e1e47-af9f-46e8-af99-43cd44187012
Public Version Date
February 28, 2019
Public Version Number
4
DI Record Publish Date
December 31, 2016
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 | 5839 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
| U | Unclassified | 20 |