| Primary Device ID | 20070942007171 |
| NIH Device Record Key | ead8118a-7d5c-45c5-9487-8ed1750905bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUM® |
| Version Model Number | 840 |
| Catalog Number | ECM6 |
| Company DUNS | 025066358 |
| Company Name | SUNSTAR AMERICAS, INC. |
| Device Count | 150 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com | |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com | |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com | |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com | |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com | |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com | |
| Phone | +1(800)777-3101 |
| contact.us@us.sunstar.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00070942007177 [Primary] |
| GS1 | 20070942007171 [Package] Contains: 00070942007177 Package: Box [24 Units] In Commercial Distribution |
| GS1 | 80070942007173 [Unit of Use] |
| JES | FLOSS, 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 | 2024-04-15 |
| Device Publish Date | 2024-04-05 |
| 00070942751704 | EASYTHREAD FLOSS |
| 00070942752312 | PROXABRUSH GO-BETWEENS CLEANERS EXTRA WIDE |
| 00070942752282 | PROXABRUSH GO-BETWEENS REFILLS WIDE |
| 00070942752275 | PROXABRUSH GO-BETWEENS REFILLS MODERATE |
| 00070942751629 | FINE FLOSS UNWAXED 4YD |
| 00070942751612 | BUTLERWEAVE WAXED |
| 00070942751575 | EEZ-THRU FLOSS MINT 4 YD |
| 00070942751537 | EXPANDING DENTAL FLOSS 4YD |
| 00070942751490 | BUTLERWEAVE WAXED TUTTI FRUTTI 4YD |
| 00070942751452 | BUTLERWEAVE MINT 4YD |
| 00070942005029 | DUAL-DEFENSE TWISTED FLOSS MINTY GREEN TEA |
| 10070942752869 | PROXABRUSH GO-BETWEENS CLEANERS TIGHT |
| 10070942752784 | PROXABRUSH GO-BETWEENS CLEANERS ULTRA TIGHT |
| 10070942752777 | PROXABRUSH GO-BETWEENS REFILLS WIDE |
| 10070942752760 | PROXABRUSH REFILLS TIGHT |
| 10070942752739 | PROXABRUSH GO-BETWEENS ANGLE CLEANERS |
| 10070942752364 | EEZ-THRU FLOSS THREADERS |
| 10070942752302 | MOUTH MIRROR |
| 10070942752265 | PROXABRUSH GO-BETWEENS CLEANERS VARIETY PACK |
| 10070942751879 | GUM FLOSSMATE FLOSS HANDLE |
| 10070942751855 | CRAYOLA KIDS FLOSSERS GRAPE |
| 10070942751848 | PROFESSIONAL CLEAN FLOSSER PICKS FRESH MINT |
| 10070942751831 | PROXABRUSH GO-BETWEENS REFILLS MODERATE |
| 10070942751602 | 12 TRAVEL TOOTHBRUSHES |
| 10070942751589 | ANGLED CLEAN FLOSSER PICKS FRESH MINT |
| 10070942751527 | 12 TRAVEL TOOTHBRUSHES |
| 10070942751473 | EASYTHREAD FLOSS PUFFY |
| 10070942307069 | PROXABRUSH GO-BETWEENS REFILLS WIDE |
| 10070942306888 | COMFORT SLIDE FLOSSER PICKS FRESH MINT |
| 10070942306796 | ORTHODONTIC KIT |
| 70070942306514 | CRAYOLA KIDS' FLOSSERS GRAPE FLAVOR |
| 10070942305997 | BUTLERWEAVE FLOSS 200YD |
| 10070942305980 | FINE FLOSS MINT WAXED |
| 10070942304549 | EASYTHREAD FLOSS PUFFY |
| 10070942304440 | COMFORT SLIDE FLOSSER PICKS FRESH MINT |
| 10070942304389 | ADVANCED CARE FLOSSER PICKS FRESH MINT |
| 10070942304174 | ANGLED CLEAN FLOSSER PICKS FRESH MINT |
| 00070942303194 | MINT WAXED DENTAL FLOSS 140 YD |
| 10070942303108 | CRAYOLA KID'S FLOSSERS |
| 10070942302835 | PROXABRUSH GO-BETWEENS ANGLE CLEANERS |
| 10070942302729 | ORAL CARE CLEANING KIT |
| 10070942302408 | EXPANDING DENTAL FLOSS 40M |
| 10070942302392 | PROFESSIONAL CLEAN FLOSSER PICKS FRESH MINT |
| 80070942302384 | FLOSSERS |
| 10070942302217 | EXPANDING DENTAL FLOSS 30M |
| 10070942302156 | BUTLERWEAVE DENTAL FLOSS SPECIAL WEAVE 24YD |
| 10070942127537 | SUPER TIP MEDIUM, PROXABRUSH GO-BETWEENS |
| 10070942127520 | SUPER TIP SOFT/COMPACT, PROXABRUSH GO-BETWEENS |
| 10070942127513 | SUPER TIP SOFT/REGULAR, PROXABRUSH GO-BETWEENS |
| 10070942127469 | MICROTIP MEDIUM, PROXABRUSH GO-BETWEENS |