FDA.reportPublic FDA data

Trays

Primary DI
00842102115776
Brand
Trays
Company
FLEXBAR MACHINE CORPORATION
Model
PDT-5712
Device description
FlexArm Sterilization Tray
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102115776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102115776008421021157768421021157760842102115776

GMDN Terms#

Term, Definition table
TermDefinition
Device 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
047644935
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842102116506StrongArm Surgical Holders and Positioners73041-XL2026-10-07
00842102116469Flexarm Surgical Holders and Positioners998002026-08-03
00842102116452Deluxe Laparoscopic Instruments91491-D-CF-452026-07-28
00842102105029Mediflex Fiber Optic Lightwand72078720782016-09-17
00842102116445Holders and Positioners - DynaTrac78002-2HP2026-04-08
00842102116438Mini-Bookler Table Mounted Retractor Systems72239-B2026-03-30
00842102116421Bookler Table Mounted Retractor Systems72072-42026-03-19
00842102116391Bookler Table Mounted Retractor Systems757072026-02-09
00842102116407Bookler Table Mounted Retractor Systems69615-102026-02-09
00842102116384StrongArm Surgical Holders and Positioners212812025-11-26
00842102114618Bookler Table Mounted Retractor Systems550122021-08-18
00842102116377Bookler Table Mounted Retractor Systems750662025-09-12
00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11

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Primary DI, Brand, Company table
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10198956580961CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
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10198956604506CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604551CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605732CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605848CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605855CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956606807CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
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10198956608351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
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10198956608948CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608955CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956609341CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956610651CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
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