MEDINAUT MAX Pro

GUDID 08800038055605

MEDINAUT MAX Pro handpiece

IMEDICOM CO., LTD.

Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Primary Device ID08800038055605
NIH Device Record Keye1679621-4b0d-45ba-8db4-1aec2ef2d5f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDINAUT MAX Pro
Version Model NumberBSH-100
Company DUNS690340653
Company NameIMEDICOM CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800038055605 [Primary]

FDA Product Code

KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


[08800038055605]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-23
Device Publish Date2024-04-15

Devices Manufactured by IMEDICOM CO., LTD.

08800038055605 - MEDINAUT MAX Pro2024-04-23MEDINAUT MAX Pro handpiece
08800038055605 - MEDINAUT MAX Pro2024-04-23 MEDINAUT MAX Pro handpiece
08800038058262 - SYNTH™ PLUS2024-04-02
08800038058279 - SYNTH™ PLUS2024-04-02
08800038058286 - SYNTH™ PLUS2024-04-02
08800038058293 - SYNTH™ PLUS2024-04-02
08800038058309 - SYNTH™ PLUS2024-04-02
08800038058316 - SYNTH™ PLUS BILATERAL2024-04-02
08800038058323 - SYNTH™ PLUS BILATERAL2024-04-02

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