PERLA ® TL MIS NAV NAV-BX 30 20-N

GUDID 07640450868879

PERLA TL MIS NAVIGATION INSTRUMENT BOX

SpineArt SA

Instrument tray, reusable

• Primary Device ID: 07640450868879
• NIH Device Record Key: 6ed1c085-6fc6-441f-bbae-6794d013317b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERLA ® TL MIS NAV
• Version Model Number: NAV-BX 30 20-N
• Catalog Number: NAV-BX 30 20-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640450868879 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[07640450868879]

Moist Heat or Steam Sterilization

[07640450868879]

Moist Heat or Steam Sterilization

[07640450868879]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

Devices Manufactured by SpineArt SA

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• 07640221373366 - PERLA ® TL: 2026-02-17 REDUCER - LONG PUSHER
• 07640221373373 - PERLA ® TL: 2026-02-17 SETSCREW HOLDER LONG
• 07640221373380 - PERLA ® TL: 2026-02-17 SETSCREW TIGHTENER LONG
• 07640151082482 - ROMEO 2 MIS: 2026-02-13 DILATOR TUBE # 2 PEEK
• 07640151082499 - ROMEO 2 MIS: 2026-02-13 DILATOR TUBE 3 PEEK
• 07640332477854 - PERLA ®: 2026-02-13 Head turner
• 07640375236081 - Cure OPEL-C: 2026-02-13 CURE OPEL-C TRAY - BASE