| Primary Device ID | 00190746162558 |
| NIH Device Record Key | 64faa222-67ff-4f2f-816d-fddaa62d587b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General Instruments |
| Version Model Number | 010-015 |
| Catalog Number | 010-015 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746162558 [Primary] |
| EIL | GAUGE, DEPTH, INSTRUMENT, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-17 |
| Device Publish Date | 2020-09-09 |
| 00190746150357 | INSTRUMENT REPLACEMENT BLADES FOR CAP REMOVER 10/PKG |
| 00190746162459 | INSTRUMENT NANCE CLOSING LOOP |
| 00190746162435 | INSTRUMENT SMAHA FORCEPS STRAIGHT STAINLESS STEEL W/LOCKING HANDLE |
| 00190746162428 | INSTRUMENT MATHIEU NEEDLE HOLDER SUPER FINE TIPS STAINLESS STEEL W/LOCKING |
| 00190746162480 | INSTRUMENT BITE STICK HIGH HEAT 3/PKG |
| 00190746162473 | INSTRUMENT CAP REMOVER WITH 10 BLADES |
| 00190746162466 | INSTRUMENT NANCE TIE BACK |
| 00190746162442 | INSTRUMENT BAND CONTOURING |
| 00190746162411 | INSTRUMENT MATHIEU NEEDLE HOLDER NARROW TIPS STAINLESS STEEL W/LOCKING HANDLE |
| 00190746162404 | INSTRUMENT MINI MATHIEU NEEDLE HOLDER STAINLESS STEEL W/LOCKING HANDLE |
| 00190746162381 | INSTRUMENT SPEEDO LIGATURE DIRECTOR |
| 00190746162374 | INSTRUMENT HEMOSTAT 4-3/4" FINE TIP STAINLESS STEEL W/LOCKING HANDLE |
| 00190746162367 | INSTRUMENT HEMOSTAT 5" STAINLESS STEEL W/LOCKING HANDLE |
| 00190746162350 | INSTRUMENT MALLET HANDLED BAND PUSHER |
| 00190746162343 | INSTRUMENT HOLLOW CHOP |
| 00190746162336 | INSTRUMENT COLLEGE PLIERS 6" STAINLESS STEEL LONG SERRATED TIPS |
| 00190746162329 | INSTRUMENT PERRY DRESSING TWEEZERS STAINLESS STEEL SERRATED, ANGLED TIPS |
| 00190746162312 | INSTRUMENT BOONE GAUGE |
| 00190746162305 | INSTRUMENT SPATULA SINGLE ENDED |
| 00190746162299 | INSTRUMENT HEAVY DUTY WIRE CUTTER |
| 00190746162282 | INSTRUMENT DB BRACKET HOLDER W/CURVED TIP |
| 00190746162237 | INSTRUMENT DB BRACKET HOLDER W/FINE TIP |
| 00190746162183 | INSTRUMENT MOLAR TUBE HOLDER |
| 00190746162657 | INSTRUMENT DB ADHESIVE REMOVER DOUBLE ENDED |
| 00190746162589 | INSTRUMENT BAND SEATER/CEMENT SCALER DOUBLE ENDED |
| 00190746162572 | INSTRUMENT SCALER/BAND PUSHER |
| 00190746162565 | INSTRUMENT T3 OPEN/CLOSE INSTRUMENT |
| 00190746162558 | INSTRUMENT BRACKET HEIGHT GAUGE |
| 00190746162541 | INSTRUMENT DOUBLE ENDED BAND SEATER |
| 00190746134722 | INSTRUMENT SINGLE END EXPLORER STAINLESS STEEL SPRING WIRE TIP |
| 00190746134715 | INSTRUMENT DISTAL TWISTER LARGE |
| 00190746134708 | INSTRUMENT DISTAL TWISTER SMALL |
| 00190746134692 | INSTRUMENT DONTRIX GAUGE 16 OUNCE |
| 00190746134661 | INSTRUMENT LIGATURE DIRECTOR |
| 00190746134678 | INSTRUMENT POSITIVE POSITIONER HARD ANODIZED ALUMINUM |
| 00190746153259 | INSTRUMENT BRACKET PLACEMENT GUIDE 022 |
| 00190746153242 | INSTRUMENT BRACKET PLACEMENT GUIDE 018 |
| 00190746174254 | HEX HEAD DRIVER-POWERSCOPE, DISTAL JET |
| 00190746035098 | FIXED FUNCT POWERSCOPE MAGNET 5/PK |
| 00190746162398 | INSTRUMENT MATHIEU NEEDLE HOLDER STAINLESS STEEL W/LOCKING HANDLE |
| 00190746059445 | HEX HEAD DRIVER-POWERSCOPE, DISTAL JET |
| 00190746162275 | INSTRUMENT COON STYLE LIGATURE TYING PLIERS |
| 00190746162268 | INSTRUMENT DB BRACKET HOLDER KIT OF 6 001-100 |
| 00190746162251 | INSTRUMENT FORCE MODULE SEPARATOR W/ADJUSTABLE SCREW |
| 00190746162244 | INSTRUMENT FORCE MODULE SEPARATOR |
| 00190746162220 | INSTRUMENT DB BRACKET HOLDER W/ALIGNMENT TIP |
| 00190746162213 | INSTRUMENT DB BRACKET HOLDER |
| 00190746057953 | INSTRUMENT BITE STICK HIGH HEAT 3/PK |
| 00190746162206 | INSTRUMENT REPLACEMENT MOUTH MIRROR STAINLESS STEEL 5/PK |
| 00190746162190 | INSTRUMENT MOUTH MIRROR STAINLESS STEEL |