| Primary Device ID | 00885797100290 |
| NIH Device Record Key | 211772c8-1f8d-443e-bafa-db2ed953252e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RMO |
| Version Model Number | K00935-2 |
| Company DUNS | 007058183 |
| Company Name | Rmo, Inc. |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885797100290 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-05 |
| Device Publish Date | 2024-08-28 |
| 00885797789914 | ALIGNER PLIER HOLE PUNCH |
| 00000008857989 | STAINLESS STEEL OPEN-WALL ARCH HOOK, W/BALL END |
| 00000008857972 | LINGUAL BUTTONS |
| 00885797096340 | PILOT DRILL |
| 00885797693471 | Preformed Quad Helix 036 BLUE ELG SIZE 3 |
| 00885797693464 | Preformed Quad Helix 036 BLUE ELG SIZE 2 |
| 00885797693457 | Preformed Quad Helix 036 BLUE ELG SIZE 1 |
| 00885797693440 | Preformed Quad Helix 036 BLUE ELG SIZE 0 |
| 00885797610744 | EXPANSION RAPID BENT DBL ARM 13MM W/KEY |
| 00885797610737 | EXPANSION RAPID BENT DBL ARM 11MM W/KEY |
| 00885797610720 | EXPANSION RAPID BENT DBL ARM 9MM W/KEY |
| 00885797610713 | EXPANSION RAPID BENT DBL ARM 8MM W/KEY |
| 00885797610690 | EXPANSION RAPID DBL ORTHOGONAL 12MM W/KEY |
| 00885797610683 | EXPANSION RAPID DBL ORTHOGONAL 10MM W/KEY |
| 00885797610676 | EXPANSION RAPID DBL ORTHOGONAL 8MM W/KEY |
| 00885797610669 | EXPANSION MICRO SGLE ARM 11MM W/KEY |
| 00885797610652 | EXPANSION MICRO SGLE ARM 8MM W/KEY |
| 00885797081469 | RICKETTS QUAD HELIX UNIT SIZE #2 |
| 00885797081452 | RICKETTS QUAD HELIX UNIT SIZE #1 |
| 00885797578037 | SCREWDRIVER FLAT/HEX |
| 00885797545701 | FLI SL 3.0 INSTRUMENT |
| 00885797728616 | NICKEL TITANIUM MOLAR DISTALIZING SPRING .010" X .045" 21" SPOOL |
| 00885797728609 | NICKEL TITANIUM OPEN COIL SPRING .012" X .045" 21" SPOOL |
| 00885797728593 | NICKEL TITANIUM OPEN COIL SPRING .012" X .030" 21" SPOOL |
| 00885797728586 | NICKEL TITANIUM OPEN COIL SPRING .010" X .030" 21" SPOOL |
| 00885797096081 | NITI DIST SPRG STOPWD.010X.045 |
| 00885797096012 | NITI COMP SPRING OPEN.012X.045 |
| 00885797096005 | NITI COMP SPRING OPEN.012X.030 |
| 00885797095992 | NITI COMP SPRING OPEN.010X.030 |
| 00885797095947 | ELG COIL SPG 007X030 OPEN |
| 00885797095930 | ELG COIL SPG 007X028 OPEN |
| 00885797095923 | ELG COIL SPG 010X045 OPEN |
| 00885797095916 | ELG COIL SPG 010X040 OPEN |
| 00885797095909 | ELG COIL SPG 010X036 CLOSED |
| 00885797095893 | ELG COIL SPG 010X036 OPEN |
| 00885797095886 | ELG COIL SPG 010X032 OPEN |
| 00885797095879 | ELG COIL SPG 010X030 CLOSED |
| 00885797095862 | ELG COIL SPG 010X030 OPEN |
| 00885797095855 | ELG COIL SPG 010X028 OPEN |
| 00885797095848 | ELG COIL SPG 009X040 OPEN |
| 00885797095831 | ELG COIL SPG 009X036 OPEN |
| 00885797095824 | ELG COIL SPG 009X032 CLOSED |
| 00885797095817 | ELG COIL SPG 009X032 OPEN |
| 00885797095800 | ELG COIL SPG 009X030 CLOSED |
| 00885797095794 | ELG COIL SPG 009X030 OPEN |
| 00885797095787 | ELG COIL SPG 009X028 OPEN |
| 00885797095770 | ELG COIL SPG 008X036 CLOSED |
| 00885797095763 | ELG COIL SPG 008X036 OPEN |
| 00885797095756 | ELG COIL SPG 008X032 OPEN |
| 00885797095749 | ELG COIL SPG 008X030 CLOSED |