Blu-Mousse® S457-K
GUDID 00810000524211
Super-Fast Blu-Mousse® Standard-Cartridge System (Korea)
PARKELL, INC.
Silicone dental impression material| Primary Device ID | 00810000524211 |
| NIH Device Record Key | 36e4b35c-a9f1-4d8c-b27d-030c2b2230d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blu-Mousse® |
| Version Model Number | S457-K |
| Catalog Number | S457-K |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 2 |
| 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 | false |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat, light, moisture or freezing. After initial use, store in a cool, dark place. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000524211 [Unit of Use] |
| GS1 | 10810000524577 [Primary] |
FDA Product Code
| ELW | Material, Impression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-04 |
| Device Publish Date | 2021-09-24 |
On-Brand Devices [Blu-Mousse®]
| M595S4360 | Tubes of Classic Blu-Mousse® |
| M595S4571 | Super-Fast Blu-Mousse® Standard-Cartridge System |
| M595S448S1 | Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System |
| M595S440S1 | Blu-Mousse® 60 In Split-Cartridge |
| M595S4381 | Classic Blu-Mousse® Standard-Cartridge System |
| M595S437S1 | Peppermint Classic Blu-Mousse® In Split-Cartridge System |
| M595S457S0 | Super-Fast Blu-Mousse® Split-Cartridge System |
| M595S438S0 | Classic Blu-Mousse® In Split-Cartridge System |
| 00810000524211 | Super-Fast Blu-Mousse® Standard-Cartridge System (Korea) |
| 00810000524167 | Classic Blu-Mousse® in Standard Cartridges (Korea) |
| 00810000524228 | Super-Fast Blu-Mousse® Split-Cartridge System (Korea) |
| 00810000524181 | Blu-Mousse® 60 In Split-Cartridge (Korea) |
| 00810000524174 | Classic Blu-Mousse® In Split-Cartridge System (Korea) |
| 00810000524501 | Tubes of Classic Blu-Mousse® (Korea) |
| 10810000526984 | Mixing Tip for Standard Cartridge for use with Blu-Mousse® (Pkg. of 30 pcs.) |
| 10810000526977 | Snap-In Intraoral Tip for Use in S439K, S445 & S496 Mixing Tips (Pkg. of 50 pcs.) |
| 10810000524218 | Super-Fast Blu-Mousse® Standard-Cartridge System |
| 10810000524164 | Classic Blu-Mousse® Cartridges |
| 10810000524195 | Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System |
| 10810000524188 | Blu-Mousse® 60 In Split-Cartridge |
| 10810000524157 | Peppermint Classic Blu-Mousse® In Split-Cartridge System |
Trademark Results [Blu-Mousse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLU-MOUSSE 73685563 1486672 Live/Registered |
PARKELL PRODUCTS INC. 1987-09-21 |
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