TOP CUT TOP 1416M

GUDID 48033003347384

TOP CUT M 14GX160MM

H.S. HOSPITAL SERVICE SPA

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 48033003347384
• NIH Device Record Key: 1ad4ad76-48b0-4500-aed0-72593580514c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOP CUT
• Version Model Number: TOP CUT M
• Catalog Number: TOP 1416M
• 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

Device Dimensions

• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge
• Length: 160 Millimeter
• Needle Gauge: 14 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033003347386 [Primary]
GS1	48033003347384 [Package]; Contains: 08033003347386; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021525

FDA Product Code

• FCG: Biopsy Needle

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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [TOP CUT]

• 38033003347691: TOP CUT 18GX250MM
• 38033003347660: TOP CUT 18GX200MM
• 38033003347318: TOP CUT M 14GX100MM
• 08033003347294: TOP CUT 14GX100MM
• 48033003347346: TOP CUT 14GX150MM
• 48033003347384: TOP CUT M 14GX160MM