FDA.report

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033352754
Brand
4CIS® INSTRUMENT SYSTEM
Company
SOLCO BIOMEDICAL CO.,LTD.
Model
F5932-1132
Catalog number
F5932-1132
Device description
Drill 14mm
Published
2020-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800033352754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800033352754088000333527548800033352754

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687844241
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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088063735960324CIS® INSTRUMENT SYSTEM5901-06005901-06002024-04-01
088063735960494CIS® INSTRUMENT SYSTEM5901-06015901-06012024-04-01
088063735960564CIS® INSTRUMENT SYSTEM5901-06025901-06022024-04-01
088063735957834CIS® INSTRUMENT SYSTEM4990-24174990-24172024-03-20
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