Cure Medical

GUDID 00861592000348

19mm Flat Probe Accessory for the HTU-110.

LIGER MEDICAL, LLC

Electrocautery system generator, battery-powered

• Primary Device ID: 00861592000348
• NIH Device Record Key: c784a195-378c-4e84-ac53-6954aa9c6236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cure Medical
• Version Model Number: HTU-110 19mm Flat
• Company DUNS: 035280324
• Company Name: LIGER MEDICAL, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861592000348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152843

FDA Product Code

• HGI: Electrocautery, Gynecologic (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Cure Medical]

• 00861592000355: 19mm Nipple Probe Accessory for HTU-110.
• 00861592000348: 19mm Flat Probe Accessory for the HTU-110.
• 00861592000331: 16mm Flat Probe Accessory for HTU-110.
• 00861592000324: Battery-operated, hand-held thermocoagulator.