Access Needle (16 Gauge)

GUDID 00846338001513

ELLIQUENCE, LLC

Endoscopic-access dilator, single-use

• Primary Device ID: 00846338001513
• NIH Device Record Key: f281b911-5f0f-4eb1-b041-641c5444a6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Needle (16 Gauge)
• Version Model Number: N6-D4/1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00846338001513 [Primary]

FDA Product Code

• GDF: Guide, Needle, Surgical

Sterilization

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

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