| Primary Device ID | 08522530060382 |
| NIH Device Record Key | 6b5403b8-0e7e-417b-be28-f854b132cd61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Free Access II Cheek Retractor Large |
| Version Model Number | 21303100L |
| Company DUNS | 021866033 |
| Company Name | J. MORITA U.S.A., INC |
| 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 | 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 |
|---|---|
| GS1 | 08522530060382 [Primary] |
| EIF | Accessories, Retractor, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
| 08522530060382 - Free Access II Cheek Retractor Large | 2023-06-15Free Access II Lip & Cheek Retractor size L |
| 08522530060382 - Free Access II Cheek Retractor Large | 2023-06-15 Free Access II Lip & Cheek Retractor size L |
| 08522530060399 - Free Access II Cheek Retractor Small | 2023-06-15 Free Access II Lip & Cheek Retractor size S |
| 10852253006240 - Power Temp Cartridge Kit | 2023-06-15 Power Temp Temporary Cement Cartridge Kit |
| 10852253006257 - Power Temp Mini Syringe Kit | 2023-06-15 Power Temp Temporary Cement Mini Syringe Kit |
| 00852253006274 - CF Carbon Fiber Post Kit | 2021-11-05 Carbon Fiber Post used for core build up |
| 00852253006328 - GF Glass Fiber Post Kit | 2021-11-05 Root canal post for core build up |
| 00852253006090 - Perfectim Putty Type Kit | 2020-01-28 PVS Dental Impression Material |
| 10852253006011 - Perfectim 30 Second Blue Velvet | 2020-01-28 PVS Dental Impression Material |