Golz tip set 45659

GUDID 04582227377036

OSADA ELECTRIC CO.,LTD.

Dental ultrasonic surgical system handpiece tip

• Primary Device ID: 04582227377036
• NIH Device Record Key: dd4db60b-1386-49e1-886f-91d3095252c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Golz tip set
• Version Model Number: Golz tip set
• Catalog Number: 45659
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582227377036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844250

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04582227377036]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Golz tip set]

• 04582227408808: Golz tip set
• 04582227377036: Golz tip set