7D Surgical Universal Array (5)

GUDID 00628341521383

7D Surgical ULC

Surgical optical-tracking spatial marker connector

• Primary Device ID: 00628341521383
• NIH Device Record Key: 10d18c8f-7fad-49b6-a23b-c60f34523727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7D Surgical Universal Array (5)
• Version Model Number: 11-0141
• Company DUNS: 204326292
• Company Name: 7D Surgical ULC
• 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: false
• Serial Number: true
• 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	00628341521383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192140

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

[00628341521383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by 7D Surgical ULC

• 00628341521383 - 7D Surgical Universal Array (5): 2025-08-05
• 00628341521383 - 7D Surgical Universal Array (5): 2025-08-05
• 00628341521390 - 7D Surgical Universal Array (6): 2025-08-05
• 00628341521055 - 7D Surgical Iliac Dual Pin Sterilization Tray: 2024-07-29
• 00628341520850 - 7D Surgical Reference Clamp (Gator): 2023-09-18
• 00628341521024 - 7D Surgical Flex Rod Connector (4.5 mm - 100 mm): 2023-08-28
• 00628341520874 - 7D Surgical Spine Reference Clamp (Multi-Level): 2023-08-08
• 00628341520881 - 7D Surgical Iliac Cannula, 100 mm: 2023-03-01
• 00628341520898 - 7D Surgical Iliac Dilator, 100 mm: 2023-03-01