Perlane-L
GUDID 07331689111712
Q-Med AB
Dermal tissue reconstructive material, microbe-derived, anaesthetic| Primary Device ID | 07331689111712 |
| NIH Device Record Key | 4d45e900-e2fc-4b21-879e-89a00c2621b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perlane-L |
| Version Model Number | Gel 2.0 ml syringe |
| Company DUNS | 355371873 |
| Company Name | Q-Med AB |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| 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 0 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 0 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 0 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 0 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 0 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 0 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 0 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 0 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 0 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 0 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 0 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 0 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 | 07331689111712 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P040024
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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-10-10 |
On-Brand Devices [Perlane-L]
| 07331689111729 | Gel 2.0 ml syringe - demo |
| 07331689111712 | Gel 2.0 ml syringe |
| 07331689111705 | Gel 1.0 ml syringe - demo |
| 07331689111699 | Gel 1.0 ml syringe |
Trademark Results [Perlane-L]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERLANE-L 77940013 3845221 Live/Registered |
NESTLÃ SKIN HEALTH S.A. 2010-02-19 |
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