Speed pin (3.0 x 110 mm, wear part)

GUDID 07640176970511

Speed pin (3.0 x 110 mm, wear part)

Naviswiss AG

Optical surgical navigation device tracking system

• Primary Device ID: 07640176970511
• NIH Device Record Key: 44486626-346d-4a7d-aef3-4366fb136cd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speed pin (3.0 x 110 mm, wear part)
• Version Model Number: NS051
• Company DUNS: 483929829
• Company Name: Naviswiss AG
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	07640176970511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193094

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

[07640176970511]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-24
• Device Publish Date: 2024-05-16

Devices Manufactured by Naviswiss AG

• 07640176971327 - Sizer Adapter: 2025-11-26 Instrument for surgical navigation.
• 07640176970740 - Resection Checker: 2025-08-20 Surgical instrument to validate cuts
• 07640176970016 - Navigation unit: 2024-05-24 Navigation unit
• 07640176970023 - Control unit: 2024-05-24 Control unit
• 07640176970108 - Set of NAVItags (sterile, single-use): 2024-05-24 Set of NAVItags (sterile, single-use)
• 07640176970115 - Tag adapter P: 2024-05-24 Tag adapter P
• 07640176970122 - Tag adapter M (magnetic): 2024-05-24 Tag adapter M (magnetic)
• 07640176970153 - Hex screwdriver SW3.5mm (AO coupling): 2024-05-24 Hex screwdriver SW3.5mm (AO coupling)