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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.020 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC20UMAREU
In Commercial Distribution

  • D972AMC20UMAREU2 ()
  • AMC20UMAREU0 ()


  • Orthodontic archwire
.020 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC20UMAR
In Commercial Distribution

  • D972AMC20UMAR2 ()
  • AMC20UMAR0 ()


  • Orthodontic archwire
.020 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC20LMAR
In Commercial Distribution

  • D972AMC20LMAR2 ()
  • AMC20LMAR0 ()


  • Orthodontic archwire
20x20 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC2020UMAREU
In Commercial Distribution

  • D972AMC2020UMAREU2 ()
  • AMC2020UMAREU0 ()


  • Orthodontic archwire
20x20 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC2020UMAR
In Commercial Distribution

  • D972AMC2020UMAR2 ()
  • AMC2020UMAR0 ()


  • Orthodontic archwire
20x20 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC2020LMAR
In Commercial Distribution

  • D972AMC2020LMAR2 ()
  • AMC2020LMAR0 ()


  • Orthodontic archwire
19x25 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1925UMAREU
In Commercial Distribution

  • D972AMC1925UMAREU2 ()
  • AMC1925UMAREU0 ()


  • Orthodontic archwire
19x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1925UMAR
In Commercial Distribution

  • D972AMC1925UMAR2 ()
  • AMC1925UMAR0 ()


  • Orthodontic archwire
19x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1925LMAR
In Commercial Distribution

  • D972AMC1925LMAR2 ()
  • AMC1925LMAR0 ()


  • Orthodontic archwire
.018 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC18UMAREU
In Commercial Distribution

  • D972AMC18UMAREU2 ()
  • AMC18UMAREU0 ()


  • Orthodontic archwire
.018 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC18UMAR
In Commercial Distribution

  • D972AMC18UMAR2 ()
  • AMC18UMAR0 ()


  • Orthodontic archwire
18x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1825LMAR
In Commercial Distribution

  • D972AMC1825LMAR2 ()
  • AMC1825LMAR0 ()


  • Orthodontic archwire
18x18 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1818UMAREU
In Commercial Distribution

  • D972AMC1818UMAREU2 ()
  • AMC1818UMAREU0 ()


  • Orthodontic archwire
18x18 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1818UMAR
In Commercial Distribution

  • D972AMC1818UMAR2 ()
  • AMC1818UMAR0 ()


  • Orthodontic archwire
17x25 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1725UMAREU
In Commercial Distribution

  • D972AMC1725UMAREU2 ()
  • AMC1725UMAREU0 ()


  • Orthodontic archwire
17x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1725UMAR
In Commercial Distribution

  • D972AMC1725UMAR2 ()
  • AMC1725UMAR0 ()


  • Orthodontic archwire
16x22 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1622UMAREU
In Commercial Distribution

  • D972AMC1622UMAREU2 ()
  • AMC1622UMAREU0 ()


  • Orthodontic archwire
16x22 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1622UMAR
In Commercial Distribution

  • D972AMC1622UMAR2 ()
  • AMC1622UMAR0 ()


  • Orthodontic archwire
.014 Premium Thermal NiTi - Euro - U
Acme Monaco Corporation
AMC14UMAREU
In Commercial Distribution

  • D972AMC14UMAREU2 ()
  • AMC14UMAREU0 ()


  • Orthodontic archwire
.014 Premium Thermal NiTi - Nat - U
Acme Monaco Corporation
AMC14UMAR
In Commercial Distribution

  • D972AMC14UMAR2 ()
  • AMC14UMAR0 ()


  • Orthodontic archwire
.012 Premium Thermal NiTi - Euro - U
Acme Monaco Corporation
AMC12UMAREU
In Commercial Distribution

  • D972AMC12UMAREU2 ()
  • AMC12UMAREU0 ()


  • Orthodontic archwire
.012 Premium Thermal NiTi - Nat - U
Acme Monaco Corporation
AMC12UMAR
In Commercial Distribution

  • D972AMC12UMAR2 ()
  • AMC12UMAR0 ()


  • Orthodontic archwire
COMPOSITE NB TESCERA - U / BEAM GUIDE
Power Dental U.S.A. Inc.
5120
In Commercial Distribution

  • D9435120 ()
5120

  • Margin finishing dental file/rasp, reusable
  • Dental amalgam carrier
  • Dental spatula, reusable
CUSTOM PACK CB0M94R11 U OF IL
MEDTRONIC, INC.
CB0M94R11
Not in Commercial Distribution

  • 00643169842847 ()


  • Cardiopulmonary bypass system blood tubing set
CSTM U BAR SPLIT DRAPE PACK
MEDLINE INDUSTRIES, INC.
DYNJCD0269
In Commercial Distribution

  • 10889942553198 ()
DYNJCD0269

  • General surgical procedure kit, non-medicated, reusable
U H S HEART PACK SC
MEDLINE INDUSTRIES, INC.
DYNJ07951J
In Commercial Distribution

  • 10889942620807 ()
  • 40889942620808 ()
DYNJ07951J

  • General surgical procedure kit, non-medicated, single-use
U H S NEURO PACK SC
MEDLINE INDUSTRIES, INC.
DYNJ07952J
In Commercial Distribution

  • 10889942607952 ()
  • 40889942607953 ()
DYNJ07952J

  • General surgical procedure kit, non-medicated, single-use
T U R ADD ON PACK
MEDLINE INDUSTRIES, INC.
DYNJ45492B
In Commercial Distribution

  • 10889942624225 ()
  • 40889942624226 ()
DYNJ45492B

  • General surgical procedure kit, non-medicated, single-use
Drape 54 x 76IN Impervious U
Aligned Medical Solutions
PRO6017
In Commercial Distribution

  • 10850064198154 ()
  • 00850064198157 ()
PRO6017

  • General surgical procedure kit, non-medicated, single-use
#32 U OF LAVAL ENDO PLUGGER
HU-FRIEDY MFG. CO., LLC
RCP32LV
In Commercial Distribution

  • 10889950087463 ()
RCP32LV

  • Endodontic plugger
U OF FL MODIFIED #151 CRYERS
HU-FRIEDY MFG. CO., LLC
F7089
Not in Commercial Distribution

  • 10889950048761 ()
F7089

  • Tooth extraction forceps
U OF FL MODIFIED #150 CRYERS
HU-FRIEDY MFG. CO., LLC
F7088
Not in Commercial Distribution

  • 10889950048754 ()
F7088

  • Tooth extraction forceps
U S C T BIOPSY TRAY
Cardinal Health 200, LLC
MNU12BPSH9
In Commercial Distribution

  • 50888439060025 ()
  • 10888439060027 ()
MNU12BPSH9

  • General surgical procedure kit, medicated
Solitaire Se Niti 018X025 U Nat
Young Innovations, Inc.
4000-39D
Not in Commercial Distribution

  • 10843471158262 ()
  • 00843471158265 ()
4000-39D

  • Orthodontic archwire
Solitaire Se Niti 017X025 U Nat
Young Innovations, Inc.
4000-33
In Commercial Distribution

  • 10843471158255 ()
  • 00843471158258 ()
4000-33

  • Orthodontic archwire
Solitaire Ultra T° 018X018 U Nat
Young Innovations, Inc.
8000-35
In Commercial Distribution

  • 10843471158217 ()
  • 00843471158210 ()
8000-35

  • Orthodontic archwire
Solitaire Ultra T° 016X022 U Nat
Young Innovations, Inc.
8000-25
In Commercial Distribution

  • 10843471158194 ()
  • 00843471158197 ()
8000-25

  • Orthodontic archwire
Solitaire Ultra T° 018 U Nat
Young Innovations, Inc.
8000-09
In Commercial Distribution

  • 10843471158170 ()
  • 00843471158173 ()
8000-09

  • Orthodontic archwire
Solitaire Ultra T° 016 U Nat
Young Innovations, Inc.
8000-07
In Commercial Distribution

  • 10843471158156 ()
  • 00843471158159 ()
8000-07

  • Orthodontic archwire
Solitaire Ultra T° 014 U Nat
Young Innovations, Inc.
8000-05
In Commercial Distribution

  • 10843471158132 ()
  • 00843471158135 ()
8000-05

  • Orthodontic archwire
Solitaire Beta T 019X025 U Nat
Young Innovations, Inc.
7000-41
In Commercial Distribution

  • 10843471158095 ()
  • 00843471158098 ()
7000-41

  • Orthodontic archwire
Solitaire Ha Niti 021X025 U Na
Young Innovations, Inc.
5000-47
In Commercial Distribution

  • 10843471156923 ()
  • 00843471156926 ()
5000-47

  • Orthodontic archwire
Solitaire Ha Niti 0175X0175 U Nat
Young Innovations, Inc.
5000-29
In Commercial Distribution

  • 10843471156909 ()
  • 00843471156902 ()
5000-29

  • Orthodontic archwire
Solitaire Ha Niti 016X016 U Nat
Young Innovations, Inc.
5000-23
In Commercial Distribution

  • 10843471156855 ()
  • 00843471156858 ()
5000-23

  • Orthodontic archwire
Solitaire Ha Niti 016 U Nat
Young Innovations, Inc.
5000-07
In Commercial Distribution

  • 10843471156817 ()
  • 00843471156810 ()
5000-07

  • Orthodontic archwire
Solitaire Ha Niti 014 U Nat
Young Innovations, Inc.
5000-05
In Commercial Distribution

  • 10843471156787 ()
  • 00843471156780 ()
5000-05

  • Orthodontic archwire
Solitaire Se Niti 020 U Nat
Young Innovations, Inc.
4000-11
In Commercial Distribution

  • 10843471154080 ()
  • 00843471154083 ()
4000-11

  • Orthodontic archwire
Avair Roth 018 U 3X3 Hk
Young Innovations, Inc.
A1645
In Commercial Distribution

  • 10843471153779 ()
  • 00843471153772 ()
A1645

  • Orthodontic bracket, metal
Avair Roth 022 U 5X5 3Hk
Young Innovations, Inc.
A1725
In Commercial Distribution

  • 10843471153755 ()
  • 00843471153758 ()
A1725

  • Orthodontic bracket, metal
Avair Roth 022 U 5X5 345Hk
Young Innovations, Inc.
A1735
In Commercial Distribution

  • 10843471153694 ()
  • 00843471153697 ()
A1735

  • Orthodontic bracket, metal
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