File holder cord 54484

GUDID 04582227432711

OSADA ELECTRIC CO.,LTD.

Endodontic apex locator

• Primary Device ID: 04582227432711
• NIH Device Record Key: 273f7c67-935c-41b4-b69e-047aa009fda1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: File holder cord
• Version Model Number: File holder cord
• Catalog Number: 54484
• Company DUNS: 690713813
• Company Name: OSADA ELECTRIC CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582227432711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904742

FDA Product Code

• LQY: Locator, root apex

Sterilization

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

[04582227432711]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-20
• Device Publish Date: 2018-11-19

On-Brand Devices [File holder cord]

• 04582227432711: File holder cord
• 04582227343567: File holder cord