Bone marrow biopsy system

GUDID 04260632793213

Möller Medical GmbH

Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use Bone marrow biopsy needle, single-use

• Primary Device ID: 04260632793213
• NIH Device Record Key: 8a5c0a0f-88d3-4df1-90de-77c4a58caca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone marrow biopsy system
• Version Model Number: BOW-1066-08-0100
• 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	04260632793213 [Primary]
GS1	04260632793299 [Package]; 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: 2021-08-26
• Device Publish Date: 2021-08-18

On-Brand Devices [Bone marrow biopsy system]

• 04260277175832: BOW-1070-15-0041
• 04260277173203: BOW-1060-11-0150
• 04260277173197: BOW-1060-11-0100
• 04260277173180: BOW-1060-08-0150
• 04260277173135: BOW-1060-08-0100
• 04260632793367: BOW-1066-13-0100
• 04260632793350: BOW-1066-13-0062
• 04260632793343: BOW-1066-11-0150
• 04260632793336: BOW-1066-11-0125
• 04260632793329: BOW-1066-11-0100
• 04260632793312: BOW-1066-08-0150
• 04260632793305: BOW-1066-08-0125
• 04260632793213: BOW-1066-08-0100
• 04260632793206: BOW-1076-15-0100
• 04260632793190: BOW-1076-15-0050