Duns Number:108179458
Device Description: Small Parts Sterilization Basket, 1x
Catalog Number
C0256
Brand Name
MicroTargeting™ Sterilization Basket
Version/Model Number
C0256-00732
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K092192,K092192
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
73d75856-b07b-4dd5-8888-845945ec5581
Public Version Date
March 09, 2020
Public Version Number
1
DI Record Publish Date
February 29, 2020
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 |