FDA.report

OSADA XL-230

Primary DI
04580406860461
Brand
OSADA XL-230
Company
OSADA ELECTRIC CO.,LTD.
Model
XL-230
Catalog number
3192
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04580406860461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04580406860461045804068604614580406860461

GMDN Terms

TermDefinition
Dental power tool system, line-poweredAn assembly of devices designed to both bore/excavate and saw bones, teeth, and tough tissues during a dental/maxillofacial surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the cutting instruments (e.g., drills, saw blades, burs, polishing disks). The system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through the control unit. The system may operate through a dental delivery system or be freestanding and independent. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
690713813
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
false

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04580406860706ST38-90LST38-90L501172016-09-20
04580406860713ST38-90ST38-90500752016-09-20
04580406860720AP set 7AP set 7507962016-09-20
04580406860737AP point 1AP point 1460442016-09-20
04580406860744AP point 2AP point 2460452016-09-20
04580406860751AP point 3AP point 3460462016-09-20
04580406860768Diamond file A2Diamond file A2460502016-09-20
04580406860775Diamond file A3Diamond file A3460512016-09-20
04580406860782Diamond file L1Diamond file L1460472016-09-20
04582227360175ST24ST24163992016-09-20
04582227360205SC point 6SC point 6164032016-09-20
04582227360229SC point 5SC point 5164052016-09-20
04582227379610ST21BST21B500242016-09-20
04582227379849SC point 4-17SC point 4-17500762016-09-20
04582227379856SC point 4-19SC point 4-19500772016-09-20
04582227397072Plugger set#15Plugger set#15819012016-09-20
04582227397089Plugger set#20Plugger set#20819132016-09-20
04582227397096Plugger set#30Plugger set#30819252016-09-20

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