Reverso Applicator

GUDID 07290018977019

INTELIS INSTRUMENTS LTD

Radio-frequency skin surface treatment system applicator

• Primary Device ID: 07290018977019
• NIH Device Record Key: d1c0896f-a234-4fcc-a33b-43391d1762e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reverso Applicator
• Version Model Number: IS-FG-00002
• Company DUNS: 600796535
• Company Name: INTELIS INSTRUMENTS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	07290018977019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212107

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-26
• Device Publish Date: 2022-01-18

Devices Manufactured by INTELIS INSTRUMENTS LTD

• 07290018977002 - Reverso: 2022-01-26
• 07290018977019 - Reverso Applicator: 2022-01-26
• 07290018977019 - Reverso Applicator: 2022-01-26
• 07290018977026 - Reverso 160 Pin Tip Head: 2022-01-26
• 07290018977033 - Reverso 80 Pin Tip Head: 2022-01-26
• 07290018977040 - Reverso 176 Pin Tip Head: 2022-01-26
• 07290018977057 - Reverso 88 Pin Tip Head: 2022-01-26
• 07290018977064 - Reverso 44 Pin Tip Head: 2022-01-26