FDA.reportPublic FDA data

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033336020
Brand
4CIS® INSTRUMENT SYSTEM
Company
ALPHA AI CO.,LTD.
Model
5932-1212
Catalog number
5932-1212
Device description
4CIS® Pinehurst Drill 20mm
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
08800033336020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800033336020088000333360208800033336020

GMDN Terms#

Term, Definition table
TermDefinition
External spinal fixation systemAn assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. 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
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
088003138870754CIS® Spinal System and 4CIS® Low Back System62-6505562-650552026-04-15
088003138870824CIS® Spinal System and 4CIS® Low Back System62-7005062-700502026-04-15
088003138870994CIS® Spinal System and 4CIS® Low Back System62-7005562-700552026-04-15
088003138871054CIS® Spinal System and 4CIS® Low Back System62-7006062-700602026-04-15
088003138871124CIS® Spinal System and 4CIS® Low Back System62-1503062-150302026-04-15
088003138871294CIS® Spinal System and 4CIS® Low Back System62-1503562-150352026-04-15
088003138871364CIS® Spinal System and 4CIS® Low Back System62-1504062-150402026-04-15
088003138871434CIS® Spinal System and 4CIS® Low Back System62-1653062-165302026-04-15
088003138871504CIS® Spinal System and 4CIS® Low Back System62-1655062-165502026-04-15
088003138871674CIS® Spinal System and 4CIS® Low Back System62-1703062-170302026-04-15
088003138871744CIS® Spinal System and 4CIS® Low Back System62-1803562-180352026-04-15
088003138871814CIS® Spinal System and 4CIS® Low Back System62-1804062-180402026-04-15
088003138871984CIS® Spinal System and 4CIS® Low Back System62-1804562-180452026-04-15
088003138872044CIS® Spinal System and 4CIS® Low Back System4142-55504142-55502026-04-15
088003138872114CIS® Spinal System and 4CIS® Low Back System4142-65304142-65302026-04-15
088003138872284CIS® Spinal System and 4CIS® Low Back System4142-70504142-70502026-04-15

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