| Primary Device ID | 00190746133688 |
| NIH Device Record Key | 080b28fc-0817-41a5-a22f-69b522f4aba0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lingual Sheaths |
| Version Model Number | 852-141 |
| Catalog Number | 852-141 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS CORPORATION |
| 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 | true |
| 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 |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746133688 [Primary] |
| ECN | CLAMP, WIRE, ORTHODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-06 |
| Device Publish Date | 2018-07-05 |
| 00190746133701 | LINGUAL SHEATH PD |
| 00190746133695 | LINGUAL SHEATH 030 NO INDENT |
| 00190746133688 | LINGUAL SHEATH 036 SLOTTED W/INDENT |
| 00190746133671 | LINGUAL SHEATH 030 SLOTTED W/INDENT |
| 00190746133664 | LINGUAL SHEATH 036 SLOTTED NO INDENT |
| 00190746133657 | LINGUAL SHEATH 030 SLOTTED NO INDENT |
| 00190746133640 | LINGUAL SHEATH 036 W/INDENT |
| 00190746133633 | LINGUAL SHEATH 030 W/INDENT |
| 00190746133626 | LINGUAL SHEATH 036 NO INDENT |
| 00190746133145 | LINGUAL SHEATH MAX RIGHT LINGUAL 036 SLOTTED W/INDENT R=7 W/BALL HOOK D-G |
| 00190746133138 | LINGUAL SHEATH MAX LEFT LINGUAL 036 SLOTTED W/INDENT R=7 W/BALL HOOK D-G |
| 00190746133121 | LINGUAL SHEATH MAX RIGHT 036 SLOTTED W/INDENT R=7 W/LARGE BALL HOOK D-G OVER |
| 00190746133114 | LINGUAL SHEATH MAX LEFT 036 SLOTTED W/INDENT R=7 W/LARGE BALL HOOK D-G OVER |
| 00190746133107 | LINGUAL SHEATH MAX RIGHT MESIAL DISTAL BAR 030 DBL SLOTTED W/INDENT DISTAL |
| 00190746133091 | LINGUAL SHEATH MAX LEFT MESIAL DISTAL BAR 030 DBL SLOTTED W/INDENT DISTAL |
| 00190746133084 | LINGUAL SHEATH MAX RIGHT 036 W/BALL HOOK M-G 036 DBL SLOTTED W/ INDENT DISTAL |
| 00190746133077 | LINGUAL SHEATH MAX LEFT 036 W/BALL HOOK M-G 036 DBL SLOTTED W/ INDENT DISTAL |
| 00190746133060 | LINGUAL SHEATH MAX RIGHT 036 W/ID AND* BALL HOOK D-G SPECIALS 036 DBL SLOTTED |
| 00190746133053 | LINGUAL SHEATH MAX LEFT 036 W/ID AND* BALL HOOK D-G SPECIALS 036 DBL SLOTTED W/ |
| 00190746133046 | LINGUAL SHEATH 036 SLOTTED MESIAL DISTAL BAR OCCL |
| 00190746133039 | LINGUAL SHEATH MAX RIGHT 036 SLOTTED NO INDENT BALL HOOK D-G |
| 00190746133022 | LINGUAL SHEATH MAX LEFT 036 SLOTTED NO INDENT BALL HOOK D-G |
| 00190746133015 | LINGUAL SHEATH MAX RIGHT 036 W/DISTAL INDENT AND MESIAL DISTAL BAR OCCL |
| 00190746133008 | LINGUAL SHEATH MAX LEFT 036 W/DISTAL INDENT AND MESIAL DISTAL BAR OCCL |
| 00190746132995 | LINGUAL SHEATH 036 NO INDENT W/BALL HOOK CENTERED |
| 00190746132988 | LINGUAL SHEATH MAX RIGHT MESIAL DISTAL BAR 036 DBL SLOTTED W/INDENT DISTAL |
| 00190746132971 | LINGUAL SHEATH MAX LEFT MESIAL DISTAL BAR 036 DBL SLOTTED W/INDENT DISTAL |
| 00190746157004 | WELD LINGUAL SHEATH UL 036 SLOTTED W/INDENT R=7D NO HK |
| 00190746156991 | WELD LINGUAL SHEATH UR 036 SLOTTED W/INDENT R=7D NO HK |
| 00190746156984 | WELD LINGUAL SHEATH UL 036 SLOTTED W/INDENT R=7D BALL HK MES |
| 00190746156977 | WELD LINGUAL SHEATH UR 036 SLOTTED W/INDENT R=7D BALL HK MES |
| 00190746156960 | WELD LINGUAL SHEATH UL 036 W/INDENT DIST LARGE STYLE BALL HK DIST |
| 00190746156953 | WELD LINGUAL SHEATH UR 036 W/INDENT DIST LARGE STYLE BALL HK DIST |
| 00190746156939 | WELD LINGUAL SHEATH 036 DOUBLE NO INDENT M-D ROD CAP |
| 00190746146268 | WELD LINGUAL SHEATH UL 036 NO INDENT LARGE STYLE BALL HK DIST-GING |
| 00190746146251 | WELD LINGUAL SHEATH UR 036 NO INDENT LARGE STYLE BALL HK DIST-GING |