FDA.reportPublic FDA data

Sterilization Case, PDCMF (AXS™ NEURO DRIVER Storage and Transport Tray)

Primary DI
00856482008276
Brand
Sterilization Case, PDCMF (AXS™ NEURO DRIVER Storage and Transport Tray)
Company
PRO-DEX, INC.
Model
PDCMF-SC-001
Published
2022-04-01
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
FSMTray, Surgical, Instrument
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856482008276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856482008276008564820082768564820082760856482008276

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental 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 or inserts to hold 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
00856482008108Matrix Pro II Graphics case60.000.0152020-03-11
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

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00889024699939N/AZimmer, Inc.FSM2026-10-20
00889024699946N/AZimmer, Inc.FSM2026-10-20
00889024699953Alliance Glenoid, Identity HumeralZimmer, Inc.FSM2026-10-20
G476STER16X5X1625SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-20
00385640095167INSTRUSAFESummit Medical, Inc.KCT2026-10-16
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