Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)

GUDID 00856482008252

PRO-DEX, INC.

Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, reusable
Primary Device ID00856482008252
NIH Device Record Key4436f50b-cafe-4b84-beaa-5ea4ca53c297
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)
Version Model NumberPDCMF-1000-1
Company DUNS849370358
Company NamePRO-DEX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856482008252 [Primary]

FDA Product Code

GEYMotor, Surgical Instrument, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


[00856482008252]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-11
Device Publish Date2022-04-01

Devices Manufactured by PRO-DEX, INC.

00856482008498 - Zimmer Biomet Atlas Pro-Driver Battery, Single Use2023-11-03
00856482008474 - Zimmer Biomet 90D Atlas Blade2023-06-21
00856482008184 - Zimmer Biomet Atlas Pro Driver Sterilization Container2023-06-19
00856482008436 - Zimmer Biomet Atlas Pro Driver2023-06-19
00856482008443 - Zimmer Biomet 90D Collet2023-06-19
00856482008481 - Zimmer Biomet Straight Collet2023-06-19
00856482008467 - KLS E-Coupling Adapter2023-05-31
00856482008252 - Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)2022-04-11
00856482008252 - Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)2022-04-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.