Endo Motor

GUDID 06970873260075

DENJOY DENTAL CO.,LTD

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 06970873260075
• NIH Device Record Key: 8291606c-2ad1-4b0a-971c-9e865917fd82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo Motor
• Version Model Number: iMate-II(IM2C)
• Company DUNS: 529329650
• Company Name: DENJOY DENTAL 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970873260075 [Primary]

FDA Product Code

• KIJ: Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-19

On-Brand Devices [Endo Motor ]

• 06970873260266: iMate 3
• 06970873260259: Ai Mate-II
• 06970873260198: Ai Mate-I
• 06970873260075: iMate-II(IM2C)
• 06970873260068: iMate-II
• 06970873260051: RCTI-DY(II)