MED-J

GUDID 18054301668666

Bone Marrow Biopsy and Aspiration System 8G x 10 cm

MEDAX SRL UNIPERSONALE

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: 18054301668666
• NIH Device Record Key: eb7af2d1-4560-4535-9d63-716e8b747ba6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED-J
• Version Model Number: XJ08100-00
• 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	08054301668669 [Primary]
GS1	18054301668666 [Package]; Contains: 08054301668669; 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-J]

• 18054301668703: Bone Marrow Biopsy and Aspiration System 13G x 9 cm
• 18054301668697: Bone Marrow Biopsy and Aspiration System 13G x 5 cm
• 18054301668680: Bone Marrow Biopsy and Aspiration System 11G x 15 cm
• 18054301668673: Bone Marrow Biopsy and Aspiration System 11G x 10 cm
• 18054301668666: Bone Marrow Biopsy and Aspiration System 8G x 10 cm