BMN I TYPE I 1807M

GUDID 38033003343549

BMN I TYPE 18GX09-20-53-70MM

H.S. HOSPITAL SERVICE SPA

Bone marrow biopsy needle, single-use

• Primary Device ID: 38033003343549
• NIH Device Record Key: 61c19b89-5673-4634-a21f-e81324fc45b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMN I TYPE
• Version Model Number: BMN I TYPE
• Catalog Number: I 1807M
• Company DUNS: 428898555
• Company Name: H.S. HOSPITAL SERVICE SPA
• 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: false
• 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

Customer Support Contacts

• Phone: +39069201961
• Email: hs@hshospitalservice.com

Device Dimensions

• Needle Gauge: 18 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033003343548 [Primary]
GS1	38033003343549 [Package]; Contains: 08033003343548; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020987

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: 2019-12-26
• Device Publish Date: 2019-12-18

On-Brand Devices [BMN I TYPE]

• 38033003343549: BMN I TYPE 18GX09-20-53-70MM
• 38033003343488: BMN I TYPE 14GX19-30-63-80MM