| Primary Device ID | D7750560501 |
| NIH Device Record Key | 5cd607e4-f92a-4fca-887d-e4dd57735ec3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The George Gauge Kit |
| Version Model Number | 056-050 |
| Company DUNS | 041854332 |
| Company Name | Great Lakes Dental Technologies, Ltd. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com | |
| Phone | 800-828-7626 |
| info@greatlakesdentaltech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7750560501 [Primary] |
| EHY | Tray, Impression, Preformed |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
[D7750560501]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-16 |
| Device Publish Date | 2021-02-08 |
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| D7752651011 - Titanium Molybdenum Wire | 2022-03-31 Titanium Molybdenum Wire - 14 inches in length |
| D7752651021 - Titanium Molybdenum Wire | 2022-03-31 Titanium Molybdenum Wire - 14 inches in Length |
| D7750560501 - The George Gauge Kit | 2021-02-16Ideal for mandibular repositioning, the George Gauge allows the clinician to capture the protrusive bite registration and vertical opening without relying on the patient to achieve proper positioning. Eliminates guesswork. Extremely accurate and easy to use. |
| D7750560501 - The George Gauge Kit | 2021-02-16 Ideal for mandibular repositioning, the George Gauge allows the clinician to capture the protrusive bite registration and vertic |