OSYHAND

GUDID 03760227850181

STERILE MEDICAL HANDPIECE FOR SINGLE USE

LSO MEDICAL

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 03760227850181
• NIH Device Record Key: 6eee60a9-0a41-422b-8c35-4a87ee5765e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSYHAND
• Version Model Number: OSYHAND
• Company DUNS: 263931746
• Company Name: LSO MEDICAL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com
• Phone: +33320679000
• Email: contact@lsomedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760227850174 [Primary]
GS1	03760227850181 [Package]; Contains: 03760227850174; Package: Cardboard [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073617

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-11-06
• Device Publish Date: 2016-10-12

Devices Manufactured by LSO MEDICAL

• 03760227850150 - OSYFIBRE: 2020-11-06 STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE
• 03760227850181 - OSYHAND: 2020-11-06STERILE MEDICAL HANDPIECE FOR SINGLE USE
• 03760227850181 - OSYHAND: 2020-11-06 STERILE MEDICAL HANDPIECE FOR SINGLE USE
• 03760227850204 - SMOOTHKIT+: 2020-11-06 STERILE MEDICAL HANDPIECE FOR SINGLE USE