Primary Device ID | 00889989046991 |
NIH Device Record Key | 8dafb689-b722-4f12-9b51-fb311bd22dd1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Legacy brkt |
Version Model Number | 438-0053 |
Company DUNS | 154614119 |
Company Name | ORMCO CORPORATION |
Device Count | 1 |
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 | true |
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 | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com | |
Phone | +18008541741 |
ormcocustcare@ormco.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00889989046991 [Primary] |
EJF | BRACKET, METAL, 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 | 2024-03-15 |
Device Publish Date | 2024-03-07 |
00889989047660 | U7L DB/UL 22 ROTH MT HK 0/-14/14 |
00889989047653 | U7L DB/UL 22 ROTH MT HK 0/-14/0 |
00889989047615 | U7L DB/UL 22 ANDREWS MT HK 5/-9/10 |
00889989047608 | U7L DB/UL 22 ANDREWS MT HK 0/-9/10 |
00889989047592 | U6L UDBT DB/UL 22 ROTH MTHK NO HGTUBE 0/-14/14 |
00889989047578 | U6L TBT DB/UL 2245 ROTH HK 0/-14/14 |
00889989047561 | U6L TBT DB/UL 2245 ANDREWS MT HK 0/-9/10 |
00889989047554 | U6L OBT DB/UL 2245 ROTH MT HK 0/-14/14 |
00889989047523 | U6L DB/UL 22 ROTH SS MT HK 0/-14/14 |
00889989047516 | U6L DB/UL 22 ANDREWS SS MT HK 0/-9/10 |
00889989047509 | U6L DB/UL 22 ANDREWS HK FCC 5/-9/10 |
00889989047479 | U6L CBT DB/UL 2245 ROTH MT HK 0/-14/14 |
00889989047455 | U6LCBT DBUL 2245 AND T2 HKCAP 2/-14/14 |
00889989047431 | U6L CBT DB/UL 2245 ANDREWS MT T2 HK 2/-14/14 |
00889989047424 | U6L CBT DB/UL 2245 ANDREWS MT HK 5/-9/10 |
00889989047417 | U6L CBT DB/UL 2245 ANDREWS MT HK 0/-9/10 |
00889989047370 | L7L LBBT DB/UL 22 BIOPROG MT HK 0/-27/2 |
00889989047363 | L7L DB/UL 22 SPEC MT HK 2/-10 |
00889989047356 | L7L DB/UL 22 ROTH MT HK -1/-30/4 |
00889989047318 | L7L DB/UL 22 ANDREWS MT HK 2/-31 |
00889989047295 | L6L DBT DB/UL 22 ROTH MT HK BAL -1/-30/4 |
00889989047288 | L6L DBT DB/UL 22 ROTH MT HK -1/-30/4 |
00889989047264 | L6L DBT DB/UL 22 ANDREWS MT HK 2/-30 |
00889989047257 | L6L DB/UL 22 SPEC MT HK BAL 0/-10 |
00889989047240 | L6L DB/UL 22 ROTH SS MT HK -1/-30/4 |
00889989047219 | L6L DB/UL 22 ANDREWS T2 HK FCC -1/-30/4 |
00889989047196 | L6L DB/UL 22 ANDREWS MT HK 2/-30 |
00889989047189 | L6L DB/UL 22 ANDREWS HK CAP 2/-30 |
00889989047158 | U7R DB/UL 22 ROTH MT HK 0/-14/14 |
00889989047141 | U7R DB/UL 22 ROTH MT HK 0/-14/0 |
00889989047103 | U7R DB/UL 22 ANDREWS MT HK 5/-9/10 |
00889989047097 | U7R DB/UL 22 ANDREWS MT HK 0/-9/10 |
00889989047080 | U6R UDBT DB/UL 22 ROTH MTHK NO HGTUBE 0/-14/14 |
00889989047066 | U6R TBT DB/UL 2245 ROTH HK 0/-14/14 |
00889989047059 | U6R TBT DB/UL 2245 ANDREWS MT HK 0/-9/10 |
00889989047042 | U6R OBT DB/UL 2245 ROTH MT HK 0/-14/14 |
00889989047011 | U6R DB/UL 22 ROTH SS MT HK 0/-14/14 |
00889989047004 | U6R DB/UL 22 ANDREWS SS MT HK 0/-9/10 |
00889989046991 | U6R DB/UL 22 ANDREWS HK FCC 5/-9/10 |
00889989046960 | U6R CBT DB/UL 2245 ROTH MT HK 0/-14/14 |
00889989046915 | U6R CBT DB/UL 2245 ANDREWS MT T2 HK 2/-14/14 |
00889989046908 | U6R CBT DB/UL 2245 ANDREWS MT HK 5/-9/10 |
00889989046892 | U6R CBT DB/UL 2245 ANDREWS MT HK 0/-9/10 |
00889989046878 | U6R CBT DB/UL 2245 ANDR HK CAP 0/-9/10 |
00889989046861 | L7R LBBT DB/UL 22 BIOPROG MT HK 0/-27/2 |
00889989046854 | L7R DB/UL 22 SPEC MT HK 2/-10 |
00889989046847 | L7R DB/UL 22 ROTH MT HK -1/-30/4 |
00889989046809 | L7R DB/UL 22 ANDREWS MT HK 2/-31 |
00889989046793 | L6R DBT DB/UL 22 ROTH MT HK BAL -1/-30/4 |
00889989046786 | L6R DBT DB/UL 22 ROTH MT HK -1/-30/4 |