Duns Number:849370358
Catalog Number
-
Brand Name
MatrixPRO Driver Battery Pack, Sterile
Version/Model Number
05.000.021S
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
-
Product Code
GEY
Product Code Name
Motor, Surgical Instrument, Ac-Powered
Public Device Record Key
4d1f44c6-2f1e-45de-85bc-91e48322d2e1
Public Version Date
September 14, 2022
Public Version Number
2
DI Record Publish Date
March 23, 2022
Package DI Number
10862377000116
Quantity per Package
40
Contains DI Package
00862377000119
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 21 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |