FDA.reportPublic FDA data

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033348405
Brand
4CIS® INSTRUMENT SYSTEM
Company
ALPHA AI CO.,LTD.
Model
9901-4045
Catalog number
9901-4045
Device description
4CIS® Chiron XT Rod Caddy
Published
2020-03-17
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800033348405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800033348405088000333484058800033348405

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
687844241
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800377762103Spinal Fusion Cage SystemDPUC-40J8DPUC-40J82024-02-22
08800377762127Spinal Fusion Cage SystemDPUC-40JADPUC-40JA2024-02-22
08800377762141Spinal Fusion Cage SystemDPUC-40JCDPUC-40JC2024-02-22
08800377762165Spinal Fusion Cage SystemDPUC-40JEDPUC-40JE2024-02-22
08800377762363Spinal Fusion Cage SystemDPUC-45J8DPUC-45J82024-02-22
08800377762387Spinal Fusion Cage SystemDPUC-45JADPUC-45JA2024-02-22
08800377762400Spinal Fusion Cage SystemDPUC-45JCDPUC-45JC2024-02-22
08800377762424Spinal Fusion Cage SystemDPUC-45JEDPUC-45JE2024-02-22
08800377762622Spinal Fusion Cage SystemDPUC-50J8DPUC-50J82024-02-22
08800377762646Spinal Fusion Cage SystemDPUC-50JADPUC-50JA2024-02-22
08800377762660Spinal Fusion Cage SystemDPUC-50JCDPUC-50JC2024-02-22
08800377762684Spinal Fusion Cage SystemDPUC-50JEDPUC-50JE2024-02-22
08800377762882Spinal Fusion Cage SystemDPUC-55J8DPUC-55J82024-02-22
08800377762905Spinal Fusion Cage SystemDPUC-55JADPUC-55JA2024-02-22
08800377762929Spinal Fusion Cage SystemDPUC-55JCDPUC-55JC2024-02-22
08800377762943Spinal Fusion Cage SystemDPUC-55JEDPUC-55JE2024-02-22
08800313887983SOLCO 4CIS® General Plate System96-5081096-508102026-04-21
088003138870444CIS® Spinal System and 4CIS® Low Back System62-4504562-450452026-04-15
088003138870514CIS® Spinal System and 4CIS® Low Back System62-5505062-550502026-04-15
088003138870684CIS® Spinal System and 4CIS® Low Back System62-6503062-650302026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327697209PANGEAStryker GmbHLXH2026-08-27
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00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186414ALIFSPINAL ELEMENTS, INC.LXH2026-08-26