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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SpiritMB - 00889989007459

ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
495-1410
Not in Commercial Distribution

  • 00889989007459 ()
  • 10889989007456 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007398

ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
495-0411
Not in Commercial Distribution

  • 00889989007398 ()
  • 10889989007395 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007381

ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
495-0410
Not in Commercial Distribution

  • 00889989007381 ()
  • 10889989007388 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007213

ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
494-1411
Not in Commercial Distribution

  • 00889989007213 ()
  • 10889989007210 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007206

ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
494-1410
Not in Commercial Distribution

  • 00889989007206 ()
  • 10889989007203 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007084

ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
494-0411
Not in Commercial Distribution

  • 00889989007084 ()
  • 10889989007081 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007077

ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
494-0410
Not in Commercial Distribution

  • 00889989007077 ()
  • 10889989007074 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

KLOCKNER - 08435451602329

EC G 4° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 06 GU
In Commercial Distribution

  • 08435451602329 ()
10 12 06 GU

  • Dental implant suprastructure kit

KLOCKNER - 08435451602305

EC G 4° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 05 GU
In Commercial Distribution

  • 08435451602305 ()
10 12 05 GU

  • Dental implant suprastructure kit

Vision 2 - 00817978020417

Salmonella O Group U O: 43
PRO-LAB, INCORPORATED
PLA041
In Commercial Distribution

  • 00817978020417 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Standard Edgewise - D78829276000621

TW Edge 022/U&L6 XWD
Gc Orthodontics America Inc.
29-2760-0062
In Commercial Distribution

  • D78829276000621 ()
  • D78829276000620 ()
29-2760-0062

  • Orthodontic bracket, metal

Standard Edgewise - D78829276000591

TW Edge 022/U&L6 WD
Gc Orthodontics America Inc.
29-2760-0059
In Commercial Distribution

  • D78829276000591 ()
  • D78829276000590 ()
29-2760-0059

  • Orthodontic bracket, metal

Standard Edgewise - D78829273000591

TW Edge 022/U&L3 WD
Gc Orthodontics America Inc.
29-2730-0059
In Commercial Distribution

  • D78829273000591 ()
  • D78829273000590 ()
29-2730-0059

  • Orthodontic bracket, metal

Standard Edgewise - D78829273000531

TW Edge 022/U&L3 MED
Gc Orthodontics America Inc.
29-2730-0053
In Commercial Distribution

  • D78829273000531 ()
  • D78829273000530 ()
29-2730-0053

  • Orthodontic bracket, metal

Standard Edgewise - D78826274000531

LEW 022/U&L4&5 MED
Gc Orthodontics America Inc.
26-2740-0053
In Commercial Distribution

  • D78826274000531 ()
  • D78826274000530 ()
26-2740-0053

  • Orthodontic bracket, metal

Standard Edgewise - D78826273000621

SW EDGE 022/U&L3 XWD
Gc Orthodontics America Inc.
26-2730-0062
In Commercial Distribution

  • D78826273000621 ()
  • D78826273000620 ()
26-2730-0062

  • Orthodontic bracket, metal

Standard Edgewise - D78826273000591

SW EDGE 022/U&L3 WD
Gc Orthodontics America Inc.
26-2730-0059
In Commercial Distribution

  • D78826273000591 ()
  • D78826273000590 ()
26-2730-0059

  • Orthodontic bracket, metal

EXPERIENCE® - D78820BID359331

EXM BIDI U/L 5-5 HK3
Gc Orthodontics America Inc.
20-BID3-5933
In Commercial Distribution

  • D78820BID359331 ()
20-BID3-5933

  • Orthodontic bracket, metal

Experience - D788202E0300211

EXM MBT 022 U 3-3, SP3HK
Gc Orthodontics America Inc.
20-2E03-0021
In Commercial Distribution

  • D788202E0300211 ()
20-2E03-0021

  • Orthodontic bracket, metal

EXPERIENCE® - D788202E0300201

EXM MBT 022 U 3-3, 3HK
Gc Orthodontics America Inc.
20-2E03-0020
In Commercial Distribution

  • D788202E0300201 ()
20-2E03-0020

  • Orthodontic bracket, metal

LEONE SPA - 08033707024897

CALIBRA BICUSPID BANDS UPPER KIT U
LEONE SPA
E5100-92
In Commercial Distribution

  • 08033707024897 ()
E5100-92

  • Orthodontic metal band

LMI - D788311AA3X7201

LMI ROTH 018/U/L7-7, 3HK
Gc Orthodontics America Inc.
31-1AA3-X720
In Commercial Distribution

  • D788311AA3X7201 ()
  • D788311AA3X7200 ()
31-1AA3-X720

  • Orthodontic bracket, metal

NORDENT MANUFACTURING INC - 00840018608313

DE SCALER U of TEX 103-106
NORDENT MANUFACTURING INC
SC103-106
In Commercial Distribution

  • 00840018608313 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018606494

SE PROBE U OF MICH O
NORDENT MANUFACTURING INC
PUMO
In Commercial Distribution

  • 00840018606494 ()


  • Periodontal probe, reusable

NORDENT MANUFACTURING INC - 00840018610798

SE SCALER U OF TEXAS 106
NORDENT MANUFACTURING INC
SCUT106
In Commercial Distribution

  • 00840018610798 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018610781

SE SCALERS U OF TEXAS 103
NORDENT MANUFACTURING INC
SCUT103
In Commercial Distribution

  • 00840018610781 ()


  • Manual dental scaler, reusable

BIO-ACTIVE - D78874B0U018251

BIO-ACTIVE RC U FORM B 18X25
Gc Orthodontics America Inc.
74-B0U0-1825
In Commercial Distribution

  • D78874B0U018250 ()
  • D78874B0U018251 ()
74-B0U0-1825

  • Orthodontic archwire

INITIALLOY - D78871C3U000181

INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
71-C3U0-0018
In Commercial Distribution

  • D78871C3U000180 ()
  • D78871C3U000181 ()
71-C3U0-0018

  • Orthodontic archwire

INITIALLOY - D78871C3U000141

INITIALLOY FORM C 014 U HEAVY
Gc Orthodontics America Inc.
71-C3U0-0014
In Commercial Distribution

  • D78871C3U000140 ()
  • D78871C3U000141 ()
71-C3U0-0014

  • Orthodontic archwire

INITIALLOY - D78879ACU420201

INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
79-ACU4-2020
In Commercial Distribution

  • D78879ACU420200 ()
  • D78879ACU420201 ()
79-ACU4-2020

  • Orthodontic archwire

STAINLESS STEEL - D78879A2U018251

SS RC FORM A 18X25 U
Gc Orthodontics America Inc.
79-A2U0-1825
In Commercial Distribution

  • D78879A2U018250 ()
  • D78879A2U018251 ()
79-A2U0-1825

  • Orthodontic archwire

STAINLESS STEEL - D78879A2U016161

SS RC FORM A 16X16 U
Gc Orthodontics America Inc.
79-A2U0-1616
In Commercial Distribution

  • D78879A2U016160 ()
  • D78879A2U016161 ()
79-A2U0-1616

  • Orthodontic archwire

LEONE SPA - 08033707040101

DB BRACKETS MINI 22 LAT U
LEONE SPA
F2222-901
In Commercial Distribution

  • 08033707040101 ()
F2222-901

  • Orthodontic bracket, metal

LEONE SPA - 08033707040095

DB BRACKETS MINI 22 LAT U
LEONE SPA
F2222-01
In Commercial Distribution

  • 08033707040095 ()
F2222-01

  • Orthodontic bracket, metal

LEONE SPA - 08033707040071

DB BRACKETS MINI 22 CEN U
LEONE SPA
F2221-901
In Commercial Distribution

  • 08033707040071 ()
F2221-901

  • Orthodontic bracket, metal

LEONE SPA - 08033707040064

DB BRACKETS MINI 22 CEN U
LEONE SPA
F2221-01
In Commercial Distribution

  • 08033707040064 ()
F2221-01

  • Orthodontic bracket, metal

LEONE SPA - 08033707038375

BRACKETS POS 18 CUS U/L
LEONE SPA
F2083F04
In Commercial Distribution

  • 08033707038375 ()
F2083F04

  • Orthodontic bracket, metal

LEONE SPA - 08033707038351

BRACKETS POS 18 CUS U/R
LEONE SPA
F2083E04
In Commercial Distribution

  • 08033707038351 ()
F2083E04

  • Orthodontic bracket, metal

LEONE SPA - 08033707040248

DB BRACKETS MINI 18 LAT U
LEONE SPA
F2282-901
In Commercial Distribution

  • 08033707040248 ()
F2282-901

  • Orthodontic bracket, metal

LEONE SPA - 08033707040231

DB BRACKETS MINI 18 LAT U
LEONE SPA
F2282-01
In Commercial Distribution

  • 08033707040231 ()
F2282-01

  • Orthodontic bracket, metal
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