PRECISA PRE 1807

GUDID 38033003345284

PRECISA 18GX70MM

H.S. HOSPITAL SERVICE SPA

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 38033003345284
• NIH Device Record Key: 6e49bc40-fa1d-4a6d-b096-a9c78a98e9ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECISA
• Version Model Number: PRECISA
• Catalog Number: PRE 1807
• 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	08033003345283 [Primary]
GS1	28033003345287 [Package]; Contains: 08033003345283; Package: [5 Units]; In Commercial Distribution
GS1	38033003345284 [Package]; Contains: 08033003345283; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002944

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

On-Brand Devices [PRECISA]

• 28033003345355: PRECISA 20GX100MM
• 08033003345337: PRECISA 18GX250MM
• 28033003345324: PRECISA 18GX200MM
• 28033003345300: PRECISA 18GX100MM
• 28033003345256: PRECISA 16GX200MM
• 28033003345249: PRECISA 16GX150MM
• 28033003345232: PRECISA 16GX100MM
• 28033003345201: PRECISA 14GX150MM
• 28033003345195: PRECISA 14GX100MM
• 28033003345171: PRECISA 14GX70MM
• 38033003345314: PRECISA 18GX150MM
• 38033003345284: PRECISA 18GX70MM
• 38033003345215: PRECISA 14GX200MM