LOTUS III Body

GUDID 08800035500603

LOTUS III Body

Laseroptek Co.,Ltd

General/multiple surgical solid-state laser system

• Primary Device ID: 08800035500603
• NIH Device Record Key: ddf78042-061f-46c2-8516-d10ecfc230e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTUS III Body
• Version Model Number: LOTUS III Body
• Company DUNS: 689856875
• Company Name: Laseroptek 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: 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800035500528 [Primary]
GS1	08800035500603 [Package]; Contains: 08800035500528; Package: Carton box [1 Units]; In Commercial Distribution
GS1	08800035500764 [Package]; Contains: 08800035500528; Package: Wooden Box [1 Units]; Discontinued: 2019-11-21; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182045

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-21
• Device Publish Date: 2019-01-31

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