BIOMOL BM 2210

GUDID 28033003340770

BIOMOL 22GX100MM

H.S. HOSPITAL SERVICE SPA

Soft-tissue biopsy needle, single-use

• Primary Device ID: 28033003340770
• NIH Device Record Key: b37014b3-98a4-455e-9a11-7278b57335eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMOL
• Version Model Number: BIOMOL
• Catalog Number: BM 2210
• 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
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com
• Phone: +39069201961
• Email: hs@hshospitalservice.com

Device Dimensions

• Length: 100 Millimeter
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter
• Needle Gauge: 22 Gauge
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033003340776 [Primary]
GS1	28033003340770 [Package]; Contains: 08033003340776; Package: [5 Units]; Discontinued: 2019-03-15; Not in Commercial Distribution
GS1	38033003340777 [Package]; Contains: 08033003340776; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002947

FDA Product Code

• FCG: Biopsy Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-03
• Device Publish Date: 2016-12-04

On-Brand Devices [BIOMOL]

• 28033003340770: BIOMOL 22GX100MM
• 28033003340701: BIOMOL 20GX100MM
• 38033003340555: BIOMOL 16GX90MM
• 38033003340722: BIOMOL 20GX200MM
• 08033003340714: BIOMOL 20GX150MM
• 08033003340660: BIOMOL 18GX200MM
• 38033003340654: BIOMOL 18GX150MM
• 38033003340647: BIOMOL 18GX100MM