| Primary Device ID | D7753006280 |
| NIH Device Record Key | e501a40e-743b-46bb-bb3c-d7e2c98ee675 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GL INTRAORAL MOUTH PROPS |
| Version Model Number | 300-628 |
| Catalog Number | 300-628 |
| 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 | false |
| 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 |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com | |
| Phone | 800-828-7626 |
| info@greatlakesortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7753006280 [Primary] |
| EIF | Accessories, Retractor, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
[D7753006280]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-05-18 |
| D7753006280 | GL INTRAORAL MOUTH PROPS |
| D7753006270 | GL INTRAORAL MOUTH PROPS |
| D7753006260 | GL INTRAORAL MOUTH PROPS |