FDA.reportPublic FDA data

CH24B contra head

Primary DI
04582227341341
Brand
CH24B contra head
Company
OSADA ELECTRIC CO.,LTD.
Model
CH24B
Catalog number
05832
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582227341341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582227341341045822273413414582227341341

GMDN Terms#

Term, Definition table
TermDefinition
Line-powered dental drilling/sawing system handpieceA mains electricity (AC-powered), hand-held, dental device with a low-voltage electric motor (e.g., 24 volt) that provides power to a variety of attachable cutting endpieces for: 1) rotational motion (for drill bits, burs, and other rotary devices); and 2) reciprocal/oscillating motion for saw blades, as used in dental procedures to bore/excavate/saw bones, teeth, and tough tissues. It is typically connected via an electrical cord to a dental delivery system or a freestanding independent system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690713813
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582227353498ST45ST45567312020-03-19
04580406861000SH42SH42557412016-09-29
04580406869884CSR20CSR20563262018-06-07
04580406869891CSR32CSR32563272018-06-07
04580406869921WD-5WD-5563302018-06-07
04580406869945JCH-1JCH-1563322018-06-07
04580406869952JCH-2JCH-2563332018-06-07
04580406869969PCH-1PCH-1563352018-06-07
04580406869976ACH-1ACH-1563362018-06-07
04580406870781WCH-1WCH-1564042018-09-28
04582227341457SRH reciprocating HPSRH500632016-09-20
04582227341464SOH oscillating saw HPSOH756862016-09-20
04582227341563CH07 contra headCH07417672016-09-29
04582227341570CH09 contra headCH09785262016-09-29
04582227341587CH11B contra headCH11B400982016-09-29
04582227341594CH17 contra headCH17700492016-09-29
04582227341846CS132 contra shankCS132388492016-09-29
04582227341877CS031 contra shankCS031785402016-09-29
04582227341884CS032 contra shankCS032378832016-09-29
04582227341945SH26SH26707372016-09-29

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Primary DI, Brand, Company table
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