RESTYLANE KYSSE

GUDID 08437027710070

RESTYLANE KYSSE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is indicated for injection into the lips for lip augmentation and the correction of upper perioral rhytids in patients over the age of 21.

SAIMA GLOBAL FARMA S.L.

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 08437027710070
• NIH Device Record Key: acaa9295-61aa-4cc0-b7a3-334c19a27ae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTYLANE KYSSE
• Version Model Number: Gel 1 mL Syringe
• Company DUNS: 468910220
• Company Name: SAIMA GLOBAL FARMA S.L.
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 * Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437027710070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140029

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

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: 2025-07-08
• Device Publish Date: 2025-06-30

Devices Manufactured by SAIMA GLOBAL FARMA S.L.

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• 08437027710070 - RESTYLANE KYSSE: 2025-07-08RESTYLANE KYSSE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is indicated for injection into the lips for lip augmentation and the correction of upper perioral rhytids in patients over the age of 21.
• 08437027710070 - RESTYLANE KYSSE: 2025-07-08 RESTYLANE KYSSE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lid
• 08437027710087 - RESTYLANE LYFT WITH LIDOCAINE: 2025-07-08 RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin wi
• 08437027710094 - RESTYLANE REFYNE: 2025-07-08 RESTYLANE REFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of li
• 08437027710001 - DUROLANE: 2024-11-21 DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock
• 08437027710018 - MONOVISC: 2024-11-21 MONOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in th
• 08437027710025 - ORTHOVISC: 2024-11-21 ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in t
• 08437027710049 - SYNVISC ONE: 2024-11-21 SYNVISC ONE (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hya