OSADA Enac PL5 3290

GUDID 04582227436962

OSADA ELECTRIC CO.,LTD.

Ultrasonic dental scaling/debridement system generator

• Primary Device ID: 04582227436962
• NIH Device Record Key: d4ee5b27-49c1-45c9-a167-32037c6264f3
• Commercial Distribution Discontinuation: 2018-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OSADA Enac PL5
• Version Model Number: OE-PL5
• Catalog Number: 3290
• 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: 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	04582227436962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844250

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-05
• Device Publish Date: 2016-09-20

Devices Manufactured by OSADA ELECTRIC CO.,LTD.

• 04582227353498 - ST45: 2020-03-27
• 04580406860690 - ST38-90R: 2019-02-21
• 04580406860706 - ST38-90L: 2019-02-21
• 04580406860713 - ST38-90: 2019-02-21
• 04580406860720 - AP set 7: 2019-02-21
• 04580406860737 - AP point 1: 2019-02-21
• 04580406860744 - AP point 2: 2019-02-21
• 04580406860751 - AP point 3: 2019-02-21