MED-I

GUDID 18052283956061

Bone Marrow Aspiration System 15G x 5 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

• Primary Device ID: 18052283956061
• NIH Device Record Key: 0e0aca09-5bc0-460c-86e9-080fa8e2c979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED-I
• Version Model Number: XI15050-01
• 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	08052283956064 [Primary]
GS1	18052283956061 [Package]; Contains: 08052283956064; 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: 2020-07-16
• Device Publish Date: 2020-07-08

On-Brand Devices [MED-I]

• 18052283956153: Bone Marrow Aspiration System 16G x 11 cm
• 18052283956146: Bone Marrow Aspiration System 16G x 9 cm
• 18052283956139: Bone Marrow Aspiration System 16G x 7 cm
• 18052283956122: Bone Marrow Aspiration System 16G x 5 cm
• 18052283956115: Bone Marrow Aspiration System 16G x 4 cm
• 18052283956108: Bone Marrow Aspiration System 16G x 3 cm
• 18052283956092: Bone Marrow Aspiration System 15G x 11 cm
• 18052283956085: Bone Marrow Aspiration System 15G x 9 cm
• 18052283956078: Bone Marrow Aspiration System 15G x 7 cm
• 18052283956061: Bone Marrow Aspiration System 15G x 5 cm
• 18052283956054: Bone Marrow Aspiration System 15G x 4 cm
• 18052283956047: Bone Marrow Aspiration System 15G x 3 cm