Primary Device ID | E53578A3U021280 |
NIH Device Record Key | e2559772-e7f9-4e0c-bfb8-f864daeee7a5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stainless Steel |
Version Model Number | 78-A3U0-2128 |
Catalog Number | 78-A3U0-2128 |
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 | 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(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 | E53578A3U021280 [Unit of Use] |
HIBCC | E53578A3U021281 [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 | 2022-05-09 |
Device Publish Date | 2022-04-29 |
D78879A2U018250 | SS RC FORM A 18X25 U |
D78879A2U016160 | SS RC FORM A 16X16 U |
D78879A2L018250 | SS RC FORM A 18X25L |
D78878L20000320 | SS LAB WIRE .032" 14" |
D78878E4U017250 | SS 17X25 UPR STD HI-T |
D78878A32M19250 | SS 1925 POSTED 32MM (SP) |
D78878A40M19250 | SS 1925 Posted 40mm |
D78878A38M19250 | SS 1925 POSTED 38MM (SP) |
D78878A30M19250 | SS 1925 POSTED 30MM (SP) |
D78878A2U017220 | SS REGULAR FORM A 17X22U |
D78878A2L017220 | SS REGULAR FORM A 17X22 L |
D78878A3U019250 | SS ST Form A 019x25 U Gold Tone |
E53578A3L019250 | SS ST Form A 019x25 L Gold Tone |
E53578A3L017250 | SS ST Form A 017x25 L Gold Tone |
D78866021200150 | Surgical Ball Hook .022 Pack of 10 |
D78866021100150 | Surgical Ball Hook .018 Pack of 10 |
E53578AQU019250 | SS QUAD FLEX FORM A UPPER 19X25 |
E53578AQU017250 | SS QUAD FLEX FORM A .017 x .025 Mandibul |
E53578AQU016220 | SS QUAD FLEX FORM A .016x.022 Mandibular |
E53578AQL019250 | SS QUAD FLEX FORM A LOWER 19x25 |
E53578AQL017250 | SS QUAD FLEX FORM A .017 x .025 Maxillar |
E53578AQL016220 | SS QUAD FLEX FORM A .016x.022 Maxillary |
E53578A3U021280 | SS ST FORM A 21 x 28 U GOLD TONE |
E53578A3U018250 | SS ST FORM A 18 x 25 U GOLD TONE |
E53578A3U016220 | SS ST FORM A 16 x 22 U GOLD TONE |
E53578A3L021280 | SS ST FORM A 21 x 28 L GOLD TONE |
E53578A3L018250 | SS ST FORM A 18 x 25 L GOLD TONE |
E53578A3L016220 | SS ST FORM A 16 x 22 L GOLD TONE |
E53578C4U016220 | SS HT FORM C 16 x 22 UPPER GOLD TONE |
E53578C4L016220 | SS HT FORM C 16 x 22 LOWER GOLD TONE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STAINLESS STEEL 98024489 not registered Live/Pending |
Allwo LLC 2023-06-02 |
STAINLESS STEEL 75234363 2177543 Live/Registered |
Absecon Mills, Inc. 1997-01-31 |