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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TW Edge 018/U&L6 XWD
Gc Orthodontics America Inc.
29-1760-0062
In Commercial Distribution

  • D78829176000621 ()
  • D78829176000620 ()
29-1760-0062

  • Orthodontic bracket, metal
TW Edge 018/U&L6 WD
Gc Orthodontics America Inc.
29-1760-0059
In Commercial Distribution

  • D78829176000591 ()
  • D78829176000590 ()
29-1760-0059

  • Orthodontic bracket, metal
TW Edge 018/U&L3 WD
Gc Orthodontics America Inc.
29-1730-0059
In Commercial Distribution

  • D78829173000591 ()
  • D78829173000590 ()
29-1730-0059

  • Orthodontic bracket, metal
TW Edge 018/U&L3 MED
Gc Orthodontics America Inc.
29-1730-0053
In Commercial Distribution

  • D78829173000531 ()
  • D78829173000530 ()
29-1730-0053

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

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

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

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

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

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

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

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

  • Orthodontic bracket, metal
EXM BIDI U/L 5-5 HK3
Gc Orthodontics America Inc.
20-BID3-5933
In Commercial Distribution

  • D78820BID359331 ()
20-BID3-5933

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

  • D788202E0300211 ()
20-2E03-0021

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

  • D788202E0300201 ()
20-2E03-0020

  • Orthodontic bracket, metal
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
EXPC 022 MBT U 5-5 3,4HK
Gc Orthodontics America Inc.
11-2C04-0020
In Commercial Distribution

  • D788112C0400200 ()
  • D788112C0400201 ()
11-2C04-0020

  • Orthodontic bracket, ceramic
EXMRC Roth 022 U/L5-5 3HK
Gc Orthodontics America Inc.
19-1CC3-0010
In Commercial Distribution

  • D788191CC300100 ()
  • D788191CC300101 ()
19-1CC3-0010

  • Orthodontic bracket, metal
INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
79-ACU4-2020
In Commercial Distribution

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

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

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

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

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

  • Orthodontic archwire
Reveal™ Retainer U/L Arch
HENRY SCHEIN, INC.
1359863
In Commercial Distribution

  • 10304040114329 ()
  • 00304040114322 ()
1359863

  • Orthodontic progressive aligner
U OF MARYLAND PROVISIONAL KT 1P
Peter Brasseler Holdings, LLC
5025409U0
In Commercial Distribution

  • 00887919756095 ()


  • Diamond dental bur, single-use
U OF MARYLAND DIAMOND KIT 1P
Peter Brasseler Holdings, LLC
5025408U0
In Commercial Distribution

  • 00887919756064 ()


  • Diamond dental bur, single-use
U OF SASKATCHEWAN RPD KIT 1P
Peter Brasseler Holdings, LLC
5028253U0
In Commercial Distribution

  • 00887919875925 ()


  • Diamond dental bur, single-use
U OF PITTS AMALGAM POLISH KIT
Peter Brasseler Holdings, LLC
5022540U0
In Commercial Distribution

  • 00887919673651 ()


  • Diamond dental bur, single-use
U OF TENN PROVISIONAL KIT 1P
Peter Brasseler Holdings, LLC
5021841U0
In Commercial Distribution

  • 00887919666585 ()


  • Diamond dental bur, single-use
U OF TENN REMOVABLE PARTIAL 1P
Peter Brasseler Holdings, LLC
5024878U0
In Commercial Distribution

  • 00887919729310 ()


  • Diamond dental bur, single-use
SG-5 U/C SAFE-T-GUARD 5'' AIR
COMPASS HEALTH BRANDS CORP.
SG5_FG
In Commercial Distribution

  • 00815067043415 ()


  • Limb/torso/head restraint, reusable
SG-8 U/C SAFE-T-GUARD 8'' AIR
COMPASS HEALTH BRANDS CORP.
SG8_FG
In Commercial Distribution

  • 00815067043408 ()


  • Limb/torso/head restraint, reusable
Contra Angle, Standard U, 20,000 RPM
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
75-12
Not in Commercial Distribution

  • H83475120 ()
  • 10381780506997 ()
75-12

  • Dental laboratory drilling system handpiece
Contra Angle, Standard U, 20,000 RPM
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
75-15
Not in Commercial Distribution

  • H834750150 ()
  • 10381780507017 ()
75-15

  • Dental laboratory drilling system handpiece
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#7 ST
Medacta International SA
28.2727S
In Commercial Distribution

  • 07630345774057 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#6+ ST
Medacta International SA
28.2726SM
In Commercial Distribution

  • 07630345774033 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#6 ST
Medacta International SA
28.2726S
In Commercial Distribution

  • 07630345774026 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#5+ ST
Medacta International SA
28.2725SM
In Commercial Distribution

  • 07630345773999 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#5 ST
Medacta International SA
28.2725S
In Commercial Distribution

  • 07630345773982 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#4+ ST
Medacta International SA
28.2724SM
In Commercial Distribution

  • 07630345773951 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#4 ST
Medacta International SA
28.2724S
In Commercial Distribution

  • 07630345773944 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#3+ ST
Medacta International SA
28.2723SM
In Commercial Distribution

  • 07630345773913 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#3 ST
Medacta International SA
28.2723S
In Commercial Distribution

  • 07630345773906 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#2+ ST
Medacta International SA
28.2722SM
In Commercial Distribution

  • 07630345773876 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#2 ST
Medacta International SA
28.2722S
In Commercial Distribution

  • 07630345773869 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#1+ ST
Medacta International SA
28.2721SM
In Commercial Distribution

  • 07630345773838 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#1 ST
Medacta International SA
28.2721S
In Commercial Distribution

  • 07630345773821 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#7 ST
Medacta International SA
28.2717S
In Commercial Distribution

  • 07630345773791 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#6+ ST
Medacta International SA
28.2716SM
In Commercial Distribution

  • 07630345773777 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#6 ST
Medacta International SA
28.2716S
In Commercial Distribution

  • 07630345773760 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#5+ ST
Medacta International SA
28.2715SM
In Commercial Distribution

  • 07630345773739 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#5 ST
Medacta International SA
28.2715S
In Commercial Distribution

  • 07630345773722 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#4+ ST
Medacta International SA
28.2714SM
In Commercial Distribution

  • 07630345773692 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#4 ST
Medacta International SA
28.2714S
In Commercial Distribution

  • 07630345773685 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#3+ ST
Medacta International SA
28.2713SM
In Commercial Distribution

  • 07630345773654 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee U SLIM FemPinPositioner-MRI-GMK-L-#3 ST
Medacta International SA
28.2713S
In Commercial Distribution

  • 07630345773647 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
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