FDA.reportPublic FDA data

Matrix Pro II Graphics case

Primary DI
00856482008108
Brand
Matrix Pro II Graphics case
Company
PRO-DEX, INC.
Model
60.000.015
Published
2020-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856482008108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856482008108008564820081088564820081080856482008108

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
849370358
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856482008122BATTERY PACK, KLS-SD-2000, SINGLEKLS-BP2-0012022-03-29
00860540000218MatrixPro Sterilization Case Lid60.000.0112022-03-28
00856482008252Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)PDCMF-1000-12022-04-01
00856482008283Battery Pack, Single Use, PDCMF, TadiranPDCMF-BP-0012022-04-01
00856482008016KLS E-Coupling Adapter PDEC-1000-32022-03-29
00856482008115KLS MaxDriver 2 KLS-SD-20002022-03-29
00856482008207Pro-Dex Surgical Driver PDSD-5000-12022-03-29
00856482008214Pro-Dex Surgical Driver AO Collet PDSD-5000-22022-03-29
00856482008290Pro-Dex Surgical Driver Custom Collet PDSD-5000-52022-03-29
00860540000256ProDriver Battery Pack, SinglePDBP-001-22022-03-29
00862377000119MatrixPRO Driver Battery Pack, Sterile05.000.021S2022-03-23
00856482008009Atlas Pro Driver Battery Pack, SterileAPD-BP-001S-12020-03-13
00860540000201MatrixPro sterilization case60.000.0102020-03-27
00856482008436Zimmer Biomet Atlas Pro DriverAPD-1000-42023-06-09
00856482008269MatrixPRO II Handpiece Loaner05.000.030LN2022-04-01
00860540000225MatrixPRO Driver Loaner05.000.020LN2022-04-01
00856482008245Pro-Dex Surgical Driver Medicon PDSD-5000-62022-03-29
00862377000188KLS Martin Surgical Driver, Non-Torque LimitingKLS-SD-1000-NTL2022-03-29
00862377000133KLS MARTIN SURGICAL DRIVERKLS-SD-10002022-03-28
00862377000164Atlas Pro Driver APD-1000-12022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00385640092203INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092210INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092227INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092234INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092241INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092258INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092265INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092272INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092289INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092296INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092302INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092319INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092326INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092333INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092340INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092357INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092364INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092371INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092388INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092395INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092401INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092418INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092425INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092432INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092449INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07