Manual TruCut Biopsy Cannula

GUDID 04260277173524

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: 04260277173524
• NIH Device Record Key: f4dfe647-cd1e-42a6-a090-e45b7862a4a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manual TruCut Biopsy Cannula
• Version Model Number: MBY-1050-18-0200
• 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	04260277173364 [Primary]
GS1	04260277173524 [Package]; Contains: 04260277173364; 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 [Manual TruCut Biopsy Cannula]

• 04260277173647: MBY-1050-14-0200
• 04260277173630: MBY-1050-14-0152
• 04260277173623: MBY-1050-14-0114
• 04260277173616: MBY-1050-14-0075
• 04260277173609: MBY-1050-16-0200
• 04260277173593: MBY-1050-16-0152
• 04260277173586: MBY-1050-16-0114
• 04260277173579: MBY-1050-16-0075
• 04260277173562: MBY-1050-17-0200
• 04260277173555: MBY-1050-17-0152
• 04260277173548: MBY-1050-17-0114
• 04260277173531: MBY-1050-17-0075
• 04260277173524: MBY-1050-18-0200
• 04260277173517: MBY-1050-18-0152
• 04260277173500: MBY-1050-18-0114
• 04260277173494: MBY-1050-18-0075