Duns Number:933506164
Catalog Number
-
Brand Name
Disposable Passive Array - Blunt Probe
Version/Model Number
MP1004-CM
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142344
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
23bfb554-bf86-46e2-8315-a258a3f5f778
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 26, 2017
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 | 98 |
2 | A medical device with a moderate to high risk that requires special controls. | 518 |