| Primary Device ID | 00190746079931 |
| NIH Device Record Key | 17a15107-6a19-4b72-9a2e-be0ebaa72424 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slim Tube |
| Version Model Number | 952-4001C |
| Catalog Number | 952-4001C |
| 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 | 800-558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Phone | +1(800)558-7687 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746079931 [Primary] |
| DZD | Tube, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-04-23 |
| Device Publish Date | 2017-11-17 |
| 00190746139895 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAND LEFT MOLAR T-25 R=0 .022 |
| 00190746139888 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAND RIGHT MOLAR T-25 R=0 .022 |
| 00190746139871 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAND LEFT MOLAR T-25 R=0 .018 |
| 00190746139864 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAND RIGHT MOLAR T-25 R=0 .018 |
| 00190746139857 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAX LEFT/MAND RIGHT MOLAR T-10 R=0 .022 |
| 00190746139840 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAX RIGHT/MAND LEFT MOLAR T-10 R=0 .022 |
| 00190746139833 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAX LEFT/MAND RIGHT MOLAR T-10 R=0 .018 |
| 00190746139826 | TUBE SLIM FLANGELESS NON-CONV SINGLE MAX RIGHT/MAND LEFT MOLAR T-10 R=0 .018 |
| 00190746135187 | DB TUBE SLIM MAX LEFT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135170 | DB TUBE SLIM MAX LEFT 1ST MOLAR 018 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135163 | DB TUBE SLIM MAX RIGHT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135156 | DB TUBE SLIM MAX RIGHT 1ST MOLAR 018 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135149 | DB TUBE SLIM MAX LEFT 2ND MOLAR 022 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135132 | DB TUBE SLIM MAX LEFT 2ND MOLAR 018 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135125 | DB TUBE SLIM MAX RIGHT 2ND MOLAR 022 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746135118 | DB TUBE SLIM MAX RIGHT 2ND MOLAR 018 CAST NON-CONV TQ=-10 R=10 3.8MM W/HOOK |
| 00190746080142 | DB TUBE SLIM MAX LEFT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080135 | DB TUBE SLIM MAX LEFT 1ST MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080128 | DB TUBE SLIM MAX RIGHT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080111 | DB TUBE SLIM MAX RIGHT 1ST MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080104 | DB TUBE SLIM MAND LEFT 1ST MOLAR 022 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080098 | DB TUBE SLIM MAND LEFT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080081 | DB TUBE SLIM MAND LEFT 1ST MOLAR 018 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080074 | DB TUBE SLIM MAND LEFT 1ST MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080067 | DB TUBE SLIM MAND RIGHT 1ST MOLAR 022 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080050 | DB TUBE SLIM MAND RIGHT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080043 | DB TUBE SLIM MAND RIGHT 1ST MOLAR 018 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080036 | DB TUBE SLIM MAND RIGHT 1ST MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080029 | DB TUBE SLIM MAND LEFT 2ND MOLAR 022 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080012 | DB TUBE SLIM MAX RIGHT 1ST MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746080005 | DB TUBE SLIM MAND LEFT 2ND MOLAR 018 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079993 | DB TUBE SLIM MAND LEFT 2ND MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079986 | DB TUBE SLIM MAND RIGHT 2ND MOLAR 022 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079979 | DB TUBE SLIM MAND RIGHT 2ND MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079962 | DB TUBE SLIM MAND RIGHT 2ND MOLAR 018 CAST NON-CONV TQ=-25 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079955 | DB TUBE SLIM MAND RIGHT 2ND MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079948 | DB TUBE SLIM MAX LEFT 2ND MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079931 | DB TUBE SLIM MAX LEFT 2ND MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079924 | DB TUBE SLIM MAX RIGHT 2ND MOLAR 022 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746079917 | DB TUBE SLIM MAX RIGHT 2ND MOLAR 018 CAST NON-CONV TQ=-10 R=0 3.8MM W/HOOK & MR PAD |
| 00190746163265 | DB TUBE SLIM LL 1ST MOL 022 NON-CONV T-25 R=0 3.8MM W/HK GP |
| 00190746163210 | DB TUBE SLIM LR 1ST MOL 022 NON-CONV T-25 R=0 3.8MM W/HK GP |
| 00190746156854 | DB TUBE SLIM UR 2ND MOL SGL 022 NON-CONV T-25 R=0 3.8MM W/HK |
| 00190746156847 | DB TUBE SLIM UL 2ND MOL SGL 022 NON-CONV T-25 R=0 3.8MM W/HK |
| 00190746059032 | DB TUBE SLIM UR 2ND MOL SGL 022 NON-CONV T-25 R=0 3.8MM W/HK |
| 00190746059025 | DB TUBE SLIM UL 2ND MOL SGL 022 NON-CONV T-25 R=0 3.8MM W/HK |