Zimmer Biomet Atlas Pro Driver Sterilization Container

GUDID 00856482008184

PRO-DEX, INC.

Device sterilization/disinfection container, reusable
Primary Device ID00856482008184
NIH Device Record Key569d9e27-0567-4f5f-beed-fe4e2e8f4454
Commercial Distribution StatusIn Commercial Distribution
Brand NameZimmer Biomet Atlas Pro Driver Sterilization Container
Version Model NumberAPD-SC-003
Company DUNS849370358
Company NamePRO-DEX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100856482008184 [Primary]

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

Moist Heat or Steam Sterilization


[00856482008184]

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
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

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