| Primary Device ID | 00841549118319 |
| NIH Device Record Key | 13ee0a7d-7309-4906-90d5-8ebb33e4bba5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickLine Soft Reline Material |
| Version Model Number | 220181 |
| Company DUNS | 124763728 |
| Company Name | STERNGOLD DENTAL LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00841549118319 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 00841549118319 | 50ml cartridge, 12 mixing tips |
| 00841549115967 | Introductory kit |