SOH oscillating saw HP

Primary DI
04582227341464
Brand
SOH oscillating saw HP
Company
OSADA ELECTRIC CO.,LTD.
Model
SOH
Catalog number
75686
Published
2016-09-20
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
DZHSAW, BONE, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZHSaw, Bone, Ac-PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935443000ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMSOsada Electric Co., Ltd.1994-09-20DZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582227341464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582227341464045822273414644582227341464

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, sawing, line-poweredA hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through hard/tough tissue during surgery. The device may be of the micro or macro design. It is powered from a control unit that supplies mains, stepped-down, low-voltage electricity (e.g., 24 volt) directly via an electrical connecting cable. It is typically operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690713813
Device count
1
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
04582227341341CH24B contra headCH24B058322016-09-29
04582227341457SRH reciprocating HPSRH500632016-09-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944843604923WOODPECKER,DTEGuilin Woodpecker Medical Instrument Co., Ltd.DZH2021-08-28
06944843604442WOODPECKER, DTEGuilin Woodpecker Medical Instrument Co., Ltd.DZH2021-08-19
04582227341457SRH reciprocating HPOSADA ELECTRIC CO.,LTD.DZH2016-09-20
04582227427458SSH saggittal saw HPOSADA ELECTRIC CO.,LTD.DZH2016-09-20