TOP CUT TOP 1820

GUDID 38033003347660

TOP CUT 18GX200MM

H.S. HOSPITAL SERVICE SPA

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 38033003347660
• NIH Device Record Key: b28f5158-46af-4a84-ae82-0582c80fc94d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOP CUT
• Version Model Number: TOP CUT
• Catalog Number: TOP 1820
• 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

• Length: 200 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033003347669 [Primary]
GS1	38033003347660 [Package]; Contains: 08033003347669; Package: [10 Units]; In Commercial Distribution
GS1	48033003347667 [Package]; Contains: 08033003347669; 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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-19
• Device Publish Date: 2016-12-04

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