FDA.report

MEGA PLUS SPINE SYSTEM

Primary DI
08809763502026
Brand
MEGA PLUS SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
14140
Device description
Long-Arm Breaker
Published
2023-06-14
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
FZTCutter, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809763502026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809763502026088097635020268809763502026

GMDN Terms

TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687941818
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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08809763492273MEGA PLUS MIS SPINE SYSTEM14318-302025-05-21
08809763492280MEGA PLUS MIS SPINE SYSTEM14318-402025-05-21
08809763492297MEGA PLUS SPINE SYSTEM124602025-05-21
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08809665582867MEGA PLUS MIS SPINE SYSTEM69185-852020-09-18
08809665584281MEGA PLUS MIS SPINE SYSTEM69250-552020-09-18
08809665584762MEGA PLUS MIS SPINE SYSTEM69285-852020-09-18
08809155852319MEGA PLUS SPINE SYSTEM61120-0352018-03-23
08809155852326MEGA PLUS SPINE SYSTEM61120-0452018-03-23
08809155852333MEGA PLUS SPINE SYSTEM61120-222018-03-23
08809155852340MEGA PLUS SPINE SYSTEM61120-242018-03-23
08809155852357MEGA PLUS SPINE SYSTEM61120-262018-03-23
08809155852364MEGA PLUS SPINE SYSTEM61120-282018-03-23
08809155857109MEGA PLUS SPINE SYSTEM61120-142018-03-23
08809155857116MEGA PLUS SPINE SYSTEM61120-152018-03-23
08809155857130MEGA PLUS SPINE SYSTEM61120-172018-03-23
08809155857147MEGA PLUS SPINE SYSTEM61120-182018-03-23
08809155857154MEGA PLUS SPINE SYSTEM61120-192018-03-23
08809155857178MEGA PLUS SPINE SYSTEM61120-252018-03-23
08809155857185MEGA PLUS SPINE SYSTEM61120-302018-03-23

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