Primary Device ID | D78871C3L000180 |
NIH Device Record Key | e07caf64-83e6-41df-88e4-0e65952f55df |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INITIALLOY |
Version Model Number | 71-C3L0-0018 |
Catalog Number | 71-C3L0-0018 |
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 | D78871C3L000180 [Unit of Use] |
HIBCC | D78871C3L000181 [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 |
D78879ACU420200 | INITIALLOY FORM C 018 U HEAVY |
D78871C3U000180 | INITIALLOY FORM C 018 U HEAVY |
D78871C3U000140 | INITIALLOY FORM C 014 U HEAVY |
D78871C3L000180 | INITIALLOY FORM C 018 L HEAVY |
D78871C3L000140 | INITIALLOY FORM C 014 HEAVY |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INITIALLOY 86495130 4924039 Live/Registered |
GC Corporation 2015-01-05 |
INITIALLOY 85941661 not registered Dead/Abandoned |
GC Corporation 2013-05-24 |