MatrixPRO Driver Battery Pack, Sterile - PRO-DEX, INC.

Duns Number:849370358

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More Product Details

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

Product Characteristics

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 Details

Product Code

GEY

Product Code Name

Motor, Surgical Instrument, Ac-Powered

Device Record Status

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

Additional Identifiers

Package DI Number

10862377000116

Quantity per Package

40

Contains DI Package

00862377000119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"PRO-DEX, INC." Characteristics
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