| Primary Device ID | 00652221128119 |
| NIH Device Record Key | 3bc942a3-601e-4231-b73c-c2ce22772b95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3M™ Unitek™ |
| Version Model Number | 297-869 |
| Catalog Number | 297-869 |
| Company DUNS | 008256356 |
| Company Name | 3M UNITEK CORPORATION |
| Device Count | 10 |
| 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)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00652221128119 [Primary] |
| GS1 | 80652221128115 [Unit of Use] |
| DZC | 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 | 2018-11-19 |
| Device Publish Date | 2018-10-18 |
| 00652221289445 | 358-901 CTA Digital Workflow EA |
| 00652221237064 | 3M (TM) Unitek (TM) Open-Close Instrument for the Ultra SL Sys |
| 00652221236562 | 3M (TM) UNITEK (TM) DEBONDING INSTRUMENT FOR ULTRA SL SYSTEM |
| 00652221164261 | Unitek(TM) Ligature Ties Preformed Tooth Colored Shorty .012 .in 100/Pk |
| 00652221128140 | Unitek(TM) Nitinol Super-Elastic Reverse Curve L .020 10/Pk |
| 00652221128133 | Unitek(TM) Nitinol Super-Elastic Reverse Curve U .020 10/Pk |
| 00652221128126 | Unitek(TM) Nitinol Super-Elastic Reverse Curve L .016x.025 10/Pk |
| 00652221128119 | Unitek(TM) Nitinol Super-Elastic Reverse Curve U .016x.025 10/Pk |
| 00652221073099 | Ligature Wire Preformed Coated Natural .012 .in 100/Pk |
| 00652221073075 | Auxiliary Ligature Tie Hook .014 in. 100/Pk |
| 00652221073068 | Ligature Wire Preformed .014 in. 1000/Pk |
| 00652221073051 | Ligature Wire Preformed .012 in. 1000/Pk |
| 00652221073044 | Ligature Wire Preformed .011 in. 1000/Pk |
| 00652221073037 | Ligature Wire Preformed .010 in. 1000/Pk |
| 00652221073020 | Ligature Wire Preformed .009 in. 1000/Pk |
| 00652221073013 | Ligature Wire Preformed .008 in. 1000/Pk |
| 00652221073006 | Ball Retainer Clasp .040 10/Pk |
| 00652221072993 | Ball Retainer Clasp .032 10/Pk |
| 00652221072986 | Ball Retainer Clasp .028 10/Pk |
| 00652221072979 | Ball Retainer Clasp .024 10/Pk |
| 00652221072962 | Modified Arrowhead Clasp 12 mm x .028 10/Pk |
| 00652221072955 | Modified Arrowhead Clasp 11 mm x .028 10/Pk |
| 00652221072948 | Modified Arrowhead Clasp 10 mm x .028 10/Pk |
| 00652221072931 | Modified Arrowhead Clasp 9 mm x .028 10/Pk |
| 00652221072924 | Modified Arrowhead Clasp 8 mm x .028 10/Pk |
| 00652221072917 | Modified Arrowhead Clasp 7 mm x .028 10/Pk |
| 00652221072900 | Modified Arrowhead Clasp 6 mm x .028 10/Pk |
| 00652221072894 | Modified Arrowhead Clasp 6.5 mm x .024 10/Pk |
| 00652221072887 | Modified Arrowhead Clasp 5.5 mm x .024 10/Pk |
| 00652221072870 | Unitek(TM) Hawley Retainer Size 9 Ea |
| 00652221072863 | Unitek(TM) Hawley Retainer Size 8 Ea |
| 00652221072856 | Unitek(TM) Hawley Retainer Size 7 Ea |
| 00652221072849 | Unitek(TM) Hawley Retainer Size 6 Ea |
| 00652221072832 | Unitek(TM) Hawley Retainer Size 5 Ea |
| 00652221072825 | Unitek(TM) Hawley Retainer Size 4 Ea |
| 00652221072818 | Unitek(TM) Hawley Retainer Size 3 Ea |
| 00652221072801 | Unitek(TM) Hawley Retainer Size 2 Ea |
| 00652221072795 | Unitek(TM) Hawley Retainer Size 1 Ea |
| 00652221072788 | Unitek(TM) Hawley Retainer Size 0 Ea |
| 00652221071903 | Unitek(TM) Nitinol Closed Coil Spring 12 mm Heavy 10/Pk |
| 00652221071897 | Unitek(TM) Nitinol Closed Coil Spring 12 mm Medium 10/Pk |
| 00652221071880 | Unitek(TM) Nitinol Closed Coil Spring 12 mm Light 10/Pk |
| 00652221071873 | Unitek(TM) Nitinol Open Coil Spring 17.5 mm Heavy 3/Pk |
| 00652221071866 | Unitek(TM) Nitinol Open Coil Spring 17.5 mm Medium 3/Pk |
| 00652221071859 | Nitinol Open Coil Spring 7 in. Light .030 mm 3/Pk |
| 00652221071842 | Unitek(TM) Nitinol Closed Coil Spring 9 mm Heavy 10/Pk |
| 00652221071835 | Unitek(TM) Nitinol Closed Coil Spring 9 mm Medium 10/Pk |
| 00652221071828 | Unitek(TM) Nitinol Closed Coil Spring 9 mm Light 10/Pk |
| 00652221054685 | Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .020 50/Pk |
| 00652221054678 | Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .018 50/Pk |