| Primary Device ID | D7751910221 |
| NIH Device Record Key | 6bff22dd-6c9c-44c8-8afe-d662b0741bec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLO MOUTHGUARD PINK (DZ) *I |
| Version Model Number | 191-022 |
| Catalog Number | 191-022 |
| Company DUNS | 041854332 |
| Company Name | GREAT LAKES ORTHODONTICS, LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7751910221 [Primary] |
| DYJ | Retainer, Screw Expansion, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2016-05-18 |
| D7753004000 - SM DRYFIELD KIT RED *I | 2018-10-05 SM DRYFIELD KIT RED *I |
| D7753004010 - LG DRYFIELD KIT WHITE *I | 2018-10-05 LG DRYFIELD KIT WHITE *I |
| D7753004060 - RETRACTOR - LARGE WHITE *I | 2018-10-05 RETRACTOR - LARGE WHITE *I |
| D7753004140 - RETRACTOR - SMALL RED *I | 2018-10-05 RETRACTOR - SMALL RED *I |
| D7753006120 - LARGE LIP RETRACTOR *O | 2018-10-05 LARGE LIP RETRACTOR *O |
| D7753006140 - SMALL LIP RETRACTOR *O | 2018-10-05 SMALL LIP RETRACTOR *O |
| D7753006260 - GL INTRAORAL MOUTH PROPS | 2018-10-05 GL INTRAORAL MOUTH PROPS |
| D7753006270 - GL INTRAORAL MOUTH PROPS | 2018-10-05 GL INTRAORAL MOUTH PROPS |