Duns Number:108179458
Device Description: microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or en microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder option.
Catalog Number
FC1004
Brand Name
microTargeting™ Sterile Drape Sleeves
Version/Model Number
FC1004-00141
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
K011992,K011992
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
53827fcf-7a41-43af-9d52-e489d4c23d4d
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
August 22, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |