| Primary Device ID | 50732224000386 |
| NIH Device Record Key | aaef4067-c994-43e4-a002-da6e9529b196 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Le Petit Masque |
| Version Model Number | GCAPTPK |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 50 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224000381 [Unit of Use] |
| GS1 | 10732224000388 [Primary] |
| GS1 | 50732224000386 [Package] Contains: 10732224000388 Package: [10 Units] In Commercial Distribution |
| FXX | Mask, surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-16 |
| Device Publish Date | 2022-05-06 |
| 10732224000050 - Crosstex International | 2025-07-25 (POUCH 5.25X10 SELFSEAL) |
| 30732224120233 - Isofluid Surgical Masks | 2025-07-15 With Fog Free Strip and Shield. ASTM Level 1, Blue |
| 50732224005008 - Safe-Flo Plus Saliva Ejector | 2024-12-02 White/White |
| 50732224004988 - Safe-Flo Plus Saliva Ejector | 2024-12-02 Clear/White |
| 50732224005015 - Safe-Flo Plus Saliva Ejector | 2024-12-02 White/Green, Mint Scented |
| 50732224005022 - Safe-Flo Plus Saliva Ejector | 2024-12-02 White/Pink, Bubblegum Scented |
| 00732224005508 - DentaPure 365-Day Independent Water Bottle Cartridge | 2024-09-16 Water Purification Bottle Cartridge |
| 00732224005515 - DentaPure Water Purification Municipal Cartridge | 2024-09-16 Water Purification Municipal Cartridge |