| Primary Device ID | J014660007810 |
| NIH Device Record Key | 4a02be01-cb8e-4dc1-908a-1e5d6cd1810d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dispensing Gun 4:1 |
| Version Model Number | 66000781 |
| Catalog Number | 66000781 |
| Company DUNS | 315666321 |
| Company Name | Heraeus Kulzer GmbH |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J014660007810 [Primary] |
| DZN | INSTRUMENTS, DENTAL HAND |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-17 |
| Device Publish Date | 2024-09-09 |
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| J014660007810 - Dispensing Gun 4:1 | 2024-09-17Instruments, Dental Hand |
| J014660007810 - Dispensing Gun 4:1 | 2024-09-17 Instruments, Dental Hand |
| J014660007821 - IOT yellow 96 | 2024-09-17 Syringe, Restorative and Impression Material |
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