Spinal needle

GUDID 04260277172534

Möller Medical GmbH

Soft-tissue biopsy needle, single-use

• Primary Device ID: 04260277172534
• NIH Device Record Key: 35cdcf81-224c-4c21-8190-83ab2f94cd8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal needle
• Version Model Number: FNB-1002-18-0090
• Company DUNS: 320405061
• Company Name: Möller Medical GmbH
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260277172428 [Primary]
GS1	04260277172534 [Package]; Contains: 04260277172428; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162588

FDA Product Code

• KNW: Instrument, Biopsy

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: 2018-09-17
• Device Publish Date: 2018-08-17

On-Brand Devices [Spinal needle]

• 04260277172541: FNB-1002-18-0150
• 04260277172534: FNB-1002-18-0090
• 04260277172527: FNB-1002-20-0150
• 04260277172404: FNB-1002-20-0090
• 04260277172503: FNB-1002-22-0200
• 04260277172497: FNB-1002-22-0150
• 04260277172480: FNB-1002-22-0090
• 04260277172473: FNB-1002-23-0150
• 04260277172466: FNB-1002-23-0090
• 04260277172459: FNB-1002-25-0150
• 04260277172336: FNB-1002-25-0090