ProDriver Battery Pack, Single

GUDID 00860540000256

PRO-DEX, INC.

Disposable battery pack
Primary Device ID00860540000256
NIH Device Record Key653c2ad4-fb9e-4b3c-87f0-63aae184d4d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameProDriver Battery Pack, Single
Version Model NumberPDBP-001-2
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860540000256 [Primary]
GS100860540000263 [Package]
Package: [10 Units]
In Commercial Distribution
GS100860540000270 [Package]
Package: Case [40 Units]
In Commercial Distribution

FDA Product Code

GXLScrewdriver, Skullplate
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-06
Device Publish Date2022-03-29

Devices Manufactured by PRO-DEX, INC.

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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

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