Access Needle N12218150

GUDID 05711055000086

Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy, PTC) preceding introduction of guidewires.

Mermaid Medical A/S

Interventional radiology percutaneous-access kit, single-use

• Primary Device ID: 05711055000086
• NIH Device Record Key: becf5aa6-d394-44f8-8705-8865a8f990bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Needle
• Version Model Number: N12218150
• Catalog Number: N12218150
• Company DUNS: 308951313
• Company Name: Mermaid Medical A/S
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4547108570
• Email: customer@mermaidmedical.com

Device Dimensions

• Needle Gauge: 18 Gauge
• Length: 15 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * Keep away from sunlight and keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711055000086 [Package]; Contains: 15711055000083; Package: Retail Box [20 Units]; In Commercial Distribution
GS1	15711055000083 [Primary]

FDA Product Code

• GCB: Needle, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-10
• Device Publish Date: 2019-08-05

On-Brand Devices [Access Needle]

• 05711055001922: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055001915: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055001908: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000307: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000291: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000284: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000277: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000260: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000086: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000062: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
• 05711055000055: Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,