Duns Number:963856096
Device Description: OmniSight Reflective Marker, Box of 25
Catalog Number
-
Brand Name
OmniSight™
Version/Model Number
OS7000
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
K010548,K010548
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
e8627a9c-378b-4412-8f0a-e64b26d1f74c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 25, 2016
Package DI Number
30381780252874
Quantity per Package
25
Contains DI Package
10381780252870
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 | 1079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2066 |