Duns Number:537223815
Device Description: consisting of:- 1x Joystick (141389)- 3x ea. Sterile cover PU / 50ea. (AKTORMED PROBE COVE consisting of:- 1x Joystick (141389)- 3x ea. Sterile cover PU / 50ea. (AKTORMED PROBE COVER 30cm X 178cm VE:50, 1-EACH; MICROTEK)
Catalog Number
-
Brand Name
Bundle Joystick
Version/Model Number
151690
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAY
Product Code Name
System, Surgical, Computer Controlled Instrument
Public Device Record Key
94b259bd-3bc2-4018-968b-ed6161ca7eec
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
October 14, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |