Root ZX3

GUDID 04548213056545

J.MORITA MFG.CORP.

Electrosurgical system

• Primary Device ID: 04548213056545
• NIH Device Record Key: 1829e783-8c7c-4b2c-822f-404f3b605398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Root ZX3
• Version Model Number: RZX3 Type: HF
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.CORP.
• 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: 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	04548213056545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213477

FDA Product Code

• EKZ: Unit, Electrosurgical, And Accessories, Dental

Sterilization

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

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

[04548213056545]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-05
• Device Publish Date: 2023-06-27

On-Brand Devices [Root ZX3]

• 04548213056545: RZX3 Type: HF
• 04548213056538: RZX3 Type: RCM