242633

GUDID 10886705030194

Laparoscope, High Definition Eye Piece style 5.5 mm x 30 DEGREES x 300 mm

Medos International Sàrl

Rigid optical arthroscope, reusable

• Primary Device ID: 10886705030194
• NIH Device Record Key: 6a50905f-59ed-43b0-8f3a-9f8be0c251ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 242633
• Catalog Number: 242633
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705030194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941541

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10886705030194]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-17
• Device Publish Date: 2018-02-22

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• 10705034643274 - VELYS: 2025-04-07 VELYS SPINE ARRAY BASE SET
• 10705034643281 - VELYS: 2025-04-07 VELYS BURR ADAPTOR
• 10705034643298 - VELYS: 2025-04-07 VELYS SPINE CERVICAL CLAMP L
• 10705034643304 - VELYS: 2025-04-07 VELYS SPINE CERVICAL CLAMP S
• 10705034643311 - VELYS: 2025-04-07 VELYS SPINE INSTRUMENT TRAY 1