| Primary Device ID | 05060772890068 |
| NIH Device Record Key | 3581ca3e-5de0-491a-a344-25f45c688aa0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoGap Archwire Markers |
| Version Model Number | AX-WOMOG |
| Catalog Number | AX-WOMOG |
| Company DUNS | 002092976 |
| Company Name | PHOENIX ORTHODONTICS INC |
| Device Count | 100 |
| 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 | true |
| 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 | 05060772890013 [Primary] |
| GS1 | 05060772890068 [Unit of Use] |
| 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 | 2020-08-25 |
| Device Publish Date | 2020-08-17 |
| 05060772890051 - Phoenix Elastic Attachers | 2020-08-25 ELASTIC ATTACHERS MIXED COLORS PK100 |
| 05060772890068 - OrthoGap Archwire Markers | 2020-08-25ORTHOGAP ARCHWIRE MARKERS PK100 |
| 05060772890068 - OrthoGap Archwire Markers | 2020-08-25 ORTHOGAP ARCHWIRE MARKERS PK100 |
| 05060772890075 - Phoenix Composite Buttons | 2020-08-25 COMPOSITE BONDABLE ROUND BUTTON PK10 |
| 05060772890082 - Phoenix Composite Buttons | 2020-08-25 COMPOSITE BONDABLE RECT BUTTON PK10 |
| 05060772890099 - Phoenix Optimal | 2020-08-25 OPTIMAL MBT .022 BOND BUCCAL TUBE SGL CONVERT U R 6 -14T:10DO PK10 |
| 05060772890112 - Phoenix Optimal | 2020-08-25 OPTIMAL MBT .022 BOND BUCCAL TUBE SGL CONVERT U L 6 -14T:10DO PK10 |
| 05060772890136 - Phoenix Optimal | 2020-08-25 OPTIMAL MBT .022 BOND BUCCAL TUBE SGL CONVERT L R 6 -20T:0A PK10 |
| 05060772890150 - Phoenix Optimal | 2020-08-25 OPTIMAL MBT .022 BOND BUCCAL TUBE SGL CONVERT L L 6 -20T:0A PK10 |