Ball-Handle for Trephine

GUDID 00846338006808

ELLIQUENCE, LLC

Spinal endoscopic-access system

• Primary Device ID: 00846338006808
• NIH Device Record Key: 41231c36-4821-4565-8a56-28c89693ef47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ball-Handle for Trephine
• Version Model Number: 11-2510
• Company DUNS: 019872358
• Company Name: ELLIQUENCE, LLC
• 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	00846338006808 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

[00846338006808]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

Devices Manufactured by ELLIQUENCE, LLC

• 00846338002688 - Motor: 2025-01-20
• 00846338005566 - Retractor: 2025-01-20
• 00846338005573 - Retractor: 2025-01-20
• 00846338005634 - Bone Curette: 2025-01-20
• 00846338005641 - Bone Curette: 2025-01-20
• 00846338005658 - Bone Curette: 2025-01-20
• 00846338005665 - Bone Curette: 2025-01-20
• 00846338005672 - Bone Curette: 2025-01-20