FDA.reportPublic FDA data

Trays

Primary DI
00842102114304
Brand
Trays
Company
FLEXBAR MACHINE CORPORATION
Model
87006
Device description
Cysto-Assist Sterilization Tray
Published
2020-12-16
Public version status
Update
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
00842102114304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102114304008421021143048421021143040842102114304

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument container systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable surgical instruments between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers for the transportation of sterile surgical instruments from the central sterilization station to the operating room, and the reverse for soiled instruments to be decontaminated and sterilized; the soiled-instrument containers frequently including pre-soaking capabilities. Smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. 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
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
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956516014CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956536043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956538313CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
04046826380830Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826380939Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413187Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413194Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413200Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826438180Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495800Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495954Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
00198506092343ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-29
03661219268444LANDANGERLANDANGERLRP2026-07-29
00198506093739ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-28
00642356005812SteriBestMastel Surgical Inc.LRP2026-07-28
08057639712660Box AdapterMC BIO SRLLRP2026-07-28
10198956414419CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956488236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956489189CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956492745CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956493025CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956505117CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956509214CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513488CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513716CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513778CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956520035CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523609CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27