Primary Device ID | D78870A1U022180 |
NIH Device Record Key | 5104c0b5-95de-4c06-8f0c-7d9c2c56db01 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BIO-ACTIVE |
Version Model Number | 70-A1U0-2218 |
Catalog Number | 70-A1U0-2218 |
Company DUNS | 063167128 |
Company Name | Gc Orthodontics 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)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com | |
Phone | +1(708)897-8859 |
GCOAInfo@gcorthodontics.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D78870A1U022180 [Unit of Use] |
HIBCC | D78870A1U022181 [Primary] |
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 | 2020-09-16 |
Device Publish Date | 2020-09-08 |
D78874B0U018250 | BIO-ACTIVE RC U FORM B 18X25 |
D78870A1U022180 | BIO-ACTIVWE FORM A 21/18 UPR |
D7887A1L022180 | BIO-ACTIVE FORM A 22X18 LWR |
E53574A0U018250 | BIO-ACTIVE RC U FORM A 18X25 |
E53574A0L018250 | BIO-ACTIVE RC L FORM A 18X25 |
E53570D10020200 | BIO-ACTIVE FORM D 20X20 LIGHT |
E53570D10019250 | BIO-ACTIVE FORM D 19X25 LIGHT |
E53570D10018250 | BIO-ACTIVE FORM D 18X25 LIGHT |
E53570D10018180 | BIO-ACTIVE FORM D 18X18 LIGHT |
E53570D10017250 | BIO-ACTIVE FORM D 17X LIGHT |
E53570D10016220 | BIO-ACTIVE FORM D 16X16 LIGHT |
E53570D10016160 | BIO-ACTIVE FORM D 16X16 LIGHT |
E53570D10014250 | BIO-ACTIVE FORM D 14X25 LIGHT |
E53570D10000160 | BIO-ACTIVE FORM D 016 LIGHT |
E53570D10000140 | BIO-ACTIVE FORM D 014 LIGHT |
E53570B0U016160 | BIO-ACTIVE FORM B 16X16 U |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIO-ACTIVE 85941710 4700474 Live/Registered |
GC Corporation 2013-05-24 |
BIO-ACTIVE 85532467 4287004 Live/Registered |
SOLAR SUN RINGS, INC. 2012-02-02 |
BIO-ACTIVE 85218548 not registered Dead/Abandoned |
SOLAR SUN RINGS, INC. 2011-01-14 |
BIO-ACTIVE 76440981 2911415 Live/Registered |
EXODOR TECHNOLOGIES, L.L.C. 2002-08-16 |
BIO-ACTIVE 74030045 1753329 Dead/Cancelled |
Morinaga Milk Industry Co., Ltd. 1989-11-16 |