Fullcore Biopsy Needle

GUDID 04260277175030

Möller Medical GmbH

Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use

• Primary Device ID: 04260277175030
• NIH Device Record Key: 085c61b9-bb8b-4097-8a61-6acc11e135ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fullcore Biopsy Needle
• Version Model Number: DNG-2020-16-0100
• 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	04260277174996 [Primary]
GS1	04260277175030 [Package]; Contains: 04260277174996; 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 [Fullcore Biopsy Needle]

• 04260277178109: DNG-2020-18-0250
• 04260277178086: DNG-2020-16-0250
• 04260277175061: DNG-2020-16-0200
• 04260277175054: DNG-2020-16-0160
• 04260277175047: DNG-2020-16-0150
• 04260277175030: DNG-2020-16-0100
• 04260277174767: DNG-2020-18-0200
• 04260277174750: DNG-2020-18-0160
• 04260277174743: DNG-2020-18-0100
• 04260277174705: DNG-2020-14-0200
• 04260277174699: DNG-2020-14-0160
• 04260277174651: DNG-2020-14-0100