| Primary Device ID | 00810038091488 |
| NIH Device Record Key | c8644f11-1787-4dc2-a979-1d756ee2c015 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOOP™ LED Curing Light |
| Version Model Number | CLK01-S |
| Catalog Number | CLK01-S |
| Company DUNS | 057647005 |
| Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
| Device Count | 1 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810038091488 [Primary] |
| EJL | Bur, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
[00810038091488]
High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-07 |
| Device Publish Date | 2025-02-27 |
| 00810038091488 | LOOP™ Curing Light -Service |
| 00810038091471 | LOOP™ LED Curing Light-Warranty |
| 00810038091464 | LOOP™ LED Curing Light-Sample |
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