BMN J TYPE J1115

GUDID 38033003344591

BMN J TYPE 11GX150MM

H.S. HOSPITAL SERVICE SPA

Bone marrow biopsy needle, single-use

• Primary Device ID: 38033003344591
• NIH Device Record Key: f7c48f95-2cb0-48bd-99c9-c3023768f631
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMN J TYPE
• Version Model Number: BMN J TYPE
• Catalog Number: J1115
• 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: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033003344590 [Primary]
GS1	38033003344591 [Package]; Contains: 08033003344590; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013070

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 J TYPE]

• 38033003344614: BMN J TYPE 13GX100MM
• 38033003344591: BMN J TYPE 11GX150MM
• 38033003344553: BMN J TYPE 8GX100MM
• 38033003349626: BMN J TYPE 13GX60MM