Zimmer Biomet 90D Collet

GUDID 00856482008443

PRO-DEX, INC.

Screwing power tool attachment
Primary Device ID00856482008443
NIH Device Record Keyb149a5c3-0c32-4124-a9d1-19625db58e1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameZimmer Biomet 90D Collet
Version Model NumberAPD-CA-301
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 Numberfalse
Manufacturing Datefalse
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
GS100856482008443 [Primary]

FDA Product Code

GEYMotor, Surgical Instrument, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


[00856482008443]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

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
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.