MED-B

GUDID 18052283955712

Bone Marrow Biopsy and Aspiration System 8G x 10 cm

MEDAX SRL UNIPERSONALE

Bone marrow biopsy needle, single-use

• Primary Device ID: 18052283955712
• NIH Device Record Key: bfbd018a-a02f-4e7c-8f22-1a5ccc072b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED-B
• Version Model Number: XB08100-00
• Company DUNS: 440211428
• Company Name: MEDAX SRL UNIPERSONALE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052283955715 [Primary]
GS1	18052283955712 [Package]; Contains: 08052283955715; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192099

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: 2020-07-15
• Device Publish Date: 2020-07-07

On-Brand Devices [MED-B]

• 18052283955774: Bone Marrow Biopsy and Aspiration System 13G x 15 cm
• 18052283955767: Bone Marrow Biopsy and Aspiration System 13G x 10 cm
• 18052283955750: Bone Marrow Biopsy and Aspiration System 13G x 7 cm
• 18052283955743: Bone Marrow Biopsy and Aspiration System 11G x 15 cm
• 18052283955736: Bone Marrow Biopsy and Aspiration System 11G x 10 cm
• 18052283955729: Bone Marrow Biopsy and Aspiration System 8G x 15 cm
• 18052283955712: Bone Marrow Biopsy and Aspiration System 8G x 10 cm