Reverso 44 Pin Tip Head

GUDID 07290018977064

INTELIS INSTRUMENTS LTD

Radio-frequency skin contouring system applicator tip

• Primary Device ID: 07290018977064
• NIH Device Record Key: 67cfccb1-34d6-42cd-9a57-3b5bfb0b14e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reverso 44 Pin Tip Head
• Version Model Number: IS-FG-00007
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	07290018977064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212107

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

[07290018977064]

Moist Heat or Steam Sterilization

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
• 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
• 07290018977064 - Reverso 44 Pin Tip Head: 2022-01-26