Restylane Contour
GUDID 07331689115833
Q-Med AB
Dermal tissue reconstructive material, microbe-derived, anaesthetic| Primary Device ID | 07331689115833 |
| NIH Device Record Key | 92835704-ac2c-4869-b624-4859404fa5c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Restylane Contour |
| Version Model Number | Gel 1 mL Syringe - Demo |
| Company DUNS | 355371873 |
| Company Name | Q-Med AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigeration not required |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07331689115833 [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 | 2021-07-08 |
| Device Publish Date | 2021-06-30 |
On-Brand Devices [Restylane Contour]
| 07331689115833 | Gel 1 mL Syringe - Demo |
| 07331689115826 | Gel 1 mL Syringe |
| 07331689121452 | New SKU with Transcoject Syringe demo |
| 07331689121445 | New SKU with Transcoject Syringe |
Trademark Results [Restylane Contour]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESTYLANE CONTOUR 90562083 not registered Live/Pending |
Galderma Holding SA 2021-03-05 |
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