MED-L

GUDID 18052283955842

Bone Marrow Biopsy and Aspiration System 8G x 10 cm

MEDAX SRL UNIPERSONALE

Bone marrow biopsy needle, single-use

• Primary Device ID: 18052283955842
• NIH Device Record Key: 66abb26f-3781-4c6e-b862-a4903ede74d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED-L
• Version Model Number: XL08100-0S
• 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	08052283955845 [Primary]
GS1	18052283955842 [Package]; Contains: 08052283955845; 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-L]

• 18052283955842: Bone Marrow Biopsy and Aspiration System 8G x 10 cm
• 18052283955941: Bone Marrow Biopsy and Aspiration System 11G x 15 cm
• 18052283955934: Bone Marrow Biopsy and Aspiration System 11G x 10 cm
• 18052283955927: Bone Marrow Biopsy and Aspiration System 8G x 15 cm
• 18052283955910: Bone Marrow Biopsy and Aspiration System 8G x 10 cm
• 18052283955903: Bone Marrow Biopsy and Aspiration System 13G x 15 cm
• 18052283955897: Bone Marrow Biopsy and Aspiration System 13G x 10 cm
• 18052283955880: Bone Marrow Biopsy and Aspiration System 13G x 7 cm
• 18052283955873: Bone Marrow Biopsy and Aspiration System 11G x 15 cm
• 18052283955866: Bone Marrow Biopsy and Aspiration System 11G x 10 cm
• 18052283955859: Bone Marrow Biopsy and Aspiration System 8G x 15 cm