Primary Device ID | 04548161391927 |
NIH Device Record Key | 5bc0ac62-a29b-4761-a2db-b348127b9339 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Optiglaze™ |
Version Model Number | 001534 |
Catalog Number | 001534 |
Company DUNS | 005473608 |
Company Name | Gc America Inc. |
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 | true |
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(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04548161391927 [Unit of Use] |
GS1 | 14548161391924 [Primary] |
EBD | Coating, filling material, resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-08-15 |
Device Publish Date | 2022-08-05 |
04548161391941 | Optiglaze™ Brush Holder, 2 pieces per box |
04548161391934 | Optiglaze™ Brush Round #1, 10 pieces per box |
04548161391927 | Optiglaze™ Brush Flat #1, 10 pieces per box |
14548161292122 | OPTIGLAZE™ Color Clear HV (5 mL) |
14548161292115 | OPTIGLAZE™ Color Red (2.6 mL) |
14548161292108 | OPTIGLAZE™ Color Pink (2.6 mL) |
14548161292092 | OPTIGLAZE™ Color Lavender (2.6 mL) |
14548161292085 | OPTIGLAZE™ Color Olive (2.6 mL) |
14548161292078 | OPTIGLAZE™ Color Pink Orange (2.6 mL) |
14548161292061 | OPTIGLAZE™ Color Yellow (2.6 mL) |
14548161292054 | OPTIGLAZE™ Color White (2.6 mL) |
14548161292047 | OPTIGLAZE™Color C plus (2.6 mL) |
14548161292030 | OPTIGLAZE™ Color B plus (2.6 mL) |
14548161283359 | OPTIGLAZE™ Color Red Brown (2.6 mL) |
14548161283342 | OPTIGLAZE™ Color Orange (2.6 mL) |
14548161283335 | OPTIGLAZE™ Color Ivory White (2.6 mL) |
14548161283328 | OPTIGLAZE™ Color Grey (2.6 mL) |
14548161283311 | OPTIGLAZE™ Color Clear (5 mL) |
14548161283304 | OPTIGLAZE™ Color Blue (2.6 mL) |
14548161283298 | OPTIGLAZE™ Color A plus (2.6 mL) |
14548161282765 | OPTIGLAZE™Color Complete Set Contains: All color shades (2.6 mL each) and disposable palette; |
14548161282574 | OPTIGLAZE™ OPTIGLAZE Contains: One (15 mL) bottle. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPTIGLAZE 90382442 not registered Live/Pending |
GC CORPORATION 2020-12-15 |
OPTIGLAZE 78957562 not registered Dead/Abandoned |
GC Corporation 2006-08-22 |