SH42 55587

GUDID 04582227438744

OSADA ELECTRIC CO.,LTD.

Dental power tool system handpiece, remotely-driven

• Primary Device ID: 04582227438744
• NIH Device Record Key: d862b8fa-0271-4cbc-9132-aa4348c1dcc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SH42
• Version Model Number: SH42
• Catalog Number: 55587
• Company DUNS: 690713813
• Company Name: OSADA ELECTRIC CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582227438744 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04582227438744]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-03-07

On-Brand Devices [SH42]

• 04582227438744: SH42
• 04580406861000: SH42