FDA.reportPublic FDA data

DynaPower

Primary DI
08800201100002
Brand
DynaPower
Company
DynaMedic Co.,Ltd.
Model
DMP-7000M
Published
2024-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800201100002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800201100002088002011000028800201100002

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motorized handpiece/set, electric, reusableAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695839854
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800201101931DynaPowerDMP-7000S2024-02-13
08800201100293DynaBladeDBD1112024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401944957693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944957763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944958063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
08809260475649TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-05-19
08800038060807EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08800038060814EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08809260473812TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473829TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473836TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473843TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473850TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473867TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473874TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473881TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473898TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473904TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473911TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260474598TRAUS SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475182TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475526SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475533SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475540SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475557SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08800038060784EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
08800038060791EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
10603295559511INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13