GUDID 08809974438220

Navigation MIS Tap(Modular) Ø6.5

Medyssey Co., Ltd.

Bone tap, reusable

• Primary Device ID: 08809974438220
• NIH Device Record Key: befcd1d0-5cc8-41a3-9731-36d5da9ad65a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SNXTS-S65N
• Company DUNS: 688211503
• Company Name: Medyssey Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809974438220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242806

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument
• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

[08809974438220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-19
• Device Publish Date: 2025-02-11

Devices Manufactured by Medyssey Co., Ltd.

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• 08809974438176 - Medyssey Navigation Instrument: 2025-07-16 Iliad Navigation Tap Ø 5.5
• 08809974438183 - Medyssey Navigation Instrument: 2025-07-16 Iliad Navigation Tap Ø 6.5
• 08809974438190 - Medyssey Navigation Instrument: 2025-07-16 Iliad Navigation Tap Ø 7.5
• 08809974444382 - Medyssey Navigation Instrument: 2025-07-16 Iliad Navigation Screw driver
• 08809974444412 - Medyssey Navigation Instrument: 2025-07-16 Iliad Navigation Tap Ø 4.5
• 08800311591851 - NA: 2025-07-09 Zenius MIS Awl Tap Modular (Dual, Ø4.5)
• 08800311591868 - NA: 2025-07-09 Zenius MIS Awl Tap Modular (Dual, Ø5.5)