Solesta
GUDID 00850004725016
Solesta
PALETTE LIFE SCIENCES, INC.
Anal tissue reconstructive material| Primary Device ID | 00850004725016 |
| NIH Device Record Key | d081f69f-7d48-4cdd-89b9-2b87df70d8c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solesta |
| Version Model Number | Gel 1.0 mL Syringe |
| Company DUNS | 116951700 |
| Company Name | PALETTE LIFE SCIENCES, INC. |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing and sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004725016 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P100014
FDA Product Code
| LNM | Agent, Bulking, Injectable For Gastro-Urology 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 | 2019-03-04 |
| Device Publish Date | 2019-02-01 |
Devices Manufactured by PALETTE LIFE SCIENCES, INC.
| 00850004725139 - Barrigel | 2023-03-09 Barrigel convenience kit |
| 00850004725108 - Barrigel | 2022-12-08 Hydrogel (HA) Injectable Rectal Spacer |
| 00850004725115 - Barrigel Applicator Needle | 2022-12-08 Hypodermic needles for the injection of Barrigel |
| 00850004725023 - Deflux Metal Needle | 2019-03-11 Deflux Metal Needle |
| 00850004725009 - Deflux | 2019-03-04 Deflux |
| 00850004725016 - Solesta | 2019-03-04Solesta |
| 00850004725016 - Solesta | 2019-03-04 Solesta |
Trademark Results [Solesta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLESTA 90465463 not registered Live/Pending |
Galderma Holding S.A. 2021-01-14 |
 SOLESTA 88090466 not registered Live/Pending |
Néstlé Skin Health S.A. 2018-08-23 |
 SOLESTA 78853445 3352167 Dead/Cancelled |
NESTLÃ SKIN HEALTH S.A. 2006-04-04 |
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