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

Devices Manufactured by Medos International Sàrl

• 10886705001163 - VERSALOK: 2025-05-08 Versalok Anchor with Threader Tab
• 10886705032952 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor w/ DYNACORD and Needles
• 10886705032969 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor_x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705032976 - GRYPHON X: 2025-04-30 GRYPHON X THREADED BR Anchor_x000D_ w/ DYNACORD and Needles
• 10886705032983 - GRYPHON X: 2025-04-30 GRYPHON X THREADED BR Anchor _x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705032990 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN PEEK Anchor _x000D_ w/ DYNACORD and Needles
• 10886705033003 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN PEEK Anchor _x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705033010 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor _x000D_ w/ 1.3mm PERMATAPE and Needles