HS AMICA APK16200T19V5

GUDID 08033055147200

AMICA-PROBE 16GX200MM

H.S. HOSPITAL SERVICE SPA

Microwave hyperthermia system applicator, intracorporeal

• Primary Device ID: 08033055147200
• NIH Device Record Key: 40b3abf9-3631-4e36-af55-cccaf164a152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS AMICA
• Version Model Number: AMICA-PROBE
• Catalog Number: APK16200T19V5
• 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	08033055147200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150112

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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 [HS AMICA]

• 08058983742464: AMICA-GEN RF GENERATOR 200W
• 08058983742457: AMICA-GEN MW/RF GENERATOR 140W/200W
• 08058983742068: AMICA-GEN MW GENERATOR 140W
• 08058983740941: RF AMICA-PROBE 17GX200MM EXP. TIP 20MM
• 08033055147200: AMICA-PROBE 16GX200MM
• 08058983742174: RF AMICA-PROBE 18GX70MM EXP. TIP 10MM
• 08058983742211: RF AMICA-PROBE 18GX70MM EXP. TIP 15MM
• 08058983741160: RF AMICA-PROBE 17GX150MM EXP. TIP 15MM
• 08058983741054: RF AMICA-PROBE 18GX100MM EXP. TIP 7MM
• 08058983744390: RF AMICA-PROBE 18GX70MM EXP. TIP 5MM
• 08058983744420: RF AMICA-PROBE 18GX70MM EXP. TIP 7MM
• 08058983745960: AMICA-PROBE 17GX70MM
• 08058983745762: AMICA-PROBE 18GX70MM
• 08058983745236: AMICA-PROBE 17GX100MM
• 08058983745229: AMICA-PROBE 18GX100MM
• 08058983744864: AMICA-GEN MW GENERATOR 250W
• 08058983744772: AMICA-GEN MW/RF GENERATOR 250W/200W
• 08058983746189: AMICA-PROBE 16GX320MM
• 08058983745953: AMICA-PROBE 16GX320MM
• 08058983745366: RF AMICA-PROBE 17GX350MM EXP. TIP 20MM