Bone marrow aspiration biopsy

GUDID 04260277173258

Möller Medical GmbH

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• Primary Device ID: 04260277173258
• NIH Device Record Key: 49c77ab3-76cc-4ee2-80fd-aa0ce67ae7ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone marrow aspiration biopsy
• Version Model Number: BOW-1070-15-0100
• 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	04260277173227 [Primary]
GS1	04260277173258 [Package]; Contains: 04260277173227; 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 [Bone marrow aspiration biopsy]

• 04260277173265: BOW-1070-16-0068
• 04260277173258: BOW-1070-15-0100
• 04260277173241: BOW-1070-15-0068