CSR32 handpiece 55367

GUDID 04582227436870

OSADA ELECTRIC CO.,LTD.

Line-powered dental drilling/sawing system handpiece

• Primary Device ID: 04582227436870
• NIH Device Record Key: c45c70a2-35da-4b81-83ef-1b9697a7d1b6
• Commercial Distribution Discontinuation: 2018-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CSR32 handpiece
• Version Model Number: CSR32
• Catalog Number: 55367
• 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	04582227436870 [Primary]

FDA Product Code

• EKX: HANDPIECE, DIRECT DRIVE, AC-POWERED

Sterilization

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

[04582227436870]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-29

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