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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TEW T 018/U&L4-5 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-341-22
Not in Commercial Distribution

  • D80737341221 ()
  • D80737341220 ()
37-341-22

  • Orthodontic bracket, metal
TEW T 022/U&L3 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-332-32
Not in Commercial Distribution

  • D80737332321 ()
  • D80737332320 ()
37-332-32

  • Orthodontic bracket, metal
TEW T 022/U&L3 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-332-22
Not in Commercial Distribution

  • D80737332221 ()
  • D80737332220 ()
37-332-22

  • Orthodontic bracket, metal
TEW T 018/U&L3 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-331-32
Not in Commercial Distribution

  • D80737331321 ()
  • D80737331320 ()
37-331-32

  • Orthodontic bracket, metal
TEW T 018/U&L3 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-331-22
Not in Commercial Distribution

  • D80737331221 ()
  • D80737331220 ()
37-331-22

  • Orthodontic bracket, metal
TEW 022/U&L3 NAR LP
DENTSPLY SIRONA ORTHODONTICS INC.
37-232-10
Not in Commercial Distribution

  • D80737232101 ()
  • D80737232100 ()
37-232-10

  • Orthodontic bracket, metal
Watson-Cheyne Probe u. Dissector, double ended
Avalign Technologies, Inc.
1-FK293R
In Commercial Distribution

  • 00190776369026 ()


  • Open-surgery dissector
NEWBORN RESUSCIT KIT,U OF ALA
MEDLINE INDUSTRIES, INC.
DYK1060193NR
In Commercial Distribution

  • 10884389897379 ()
  • 40884389897370 ()
DYK1060193NR

  • General surgical procedure kit, non-medicated, single-use
Absolute® Clear Retainers U/L
ORTHO ORGANIZERS, INC.
140-RT
In Commercial Distribution

  • 00190707101077 ()


  • Orthodontic progressive aligner
Reveal® Retainer U/L Arch
ORTHO ORGANIZERS, INC.
135-9863
In Commercial Distribution

  • 00190707089764 ()


  • Orthodontic progressive aligner
.022 Kit U/L 5x5 Roth
ORTHO ORGANIZERS, INC.
705-397Q
In Commercial Distribution

  • 00190707085445 ()


  • Orthodontic bracket, metal
21x25 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC2125UMAREU
In Commercial Distribution

  • D972AMC2125UMAREU2 ()
  • D972AMC2125UMAREU0 ()


  • Orthodontic archwire
21x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC2125UMAR
In Commercial Distribution

  • D972AMC2125UMAR2 ()
  • D972AMC2125UMAR0 ()


  • Orthodontic archwire
21x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC2125LMAR
In Commercial Distribution

  • D972AMC2125LMAR2 ()
  • AMC2125LMAR0 ()


  • Orthodontic archwire
.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
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
.016 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC16UMAREU
In Commercial Distribution

  • D972AMC16UMAREU2 ()
  • AMC16UMAREU0 ()


  • Orthodontic archwire
.016 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC16UMAR
In Commercial Distribution

  • D972AMC16UMAR2 ()
  • AMC16UMAR0 ()


  • 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 - Nat - U
Acme Monaco Corporation
AMC14UMAR
In Commercial Distribution

  • D972AMC14UMAR2 ()
  • AMC14UMAR0 ()


  • Orthodontic archwire
14x25 Premium Thermal NiTi - Nat - U
Acme Monaco Corporation
AMC1425UMAR
In Commercial Distribution

  • D972AMC1425UMAR2 ()
  • AMC1425UMAR0 ()


  • 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
.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 - Euro - U
Acme Monaco Corporation
AMC1825UMAREU
In Commercial Distribution

  • D972AMC1825UMAREU2 ()
  • AMC1825UMAREU0 ()


  • Orthodontic archwire
18x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1825UMAR
In Commercial Distribution

  • D972AMC1825UMAR2 ()
  • AMC1825UMAR0 ()


  • 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
16x16 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1616UMAREU
In Commercial Distribution

  • D972AMC1616UMAREU2 ()
  • AMC1616UMAREU0 ()


  • Orthodontic archwire
16x16 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1616UMAR
In Commercial Distribution

  • D972AMC1616UMAR2 ()
  • AMC1616UMAR0 ()


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

  • D972AMC14UMAREU2 ()
  • AMC14UMAREU0 ()


  • 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
CUSTOM G U T S TRAY
Cardinal Health 200, LLC
32-1395C
In Commercial Distribution

  • 50888439507940 ()
  • 10888439507942 ()
32-1395C

  • General surgical procedure kit, medicated
DRAPE,U/ SHT,SPLIT,PLAS,STERIL
MEDLINE INDUSTRIES, INC.
DYNJP2499
In Commercial Distribution

  • 40080196739463 ()
  • 10080196739462 ()

  • Length: 76 Inch
  • Width: 54 Inch
DYNJP2499

  • Patient surgical drape, single-use
TTL1LYR 16FR10ML 100%SILI CS U
MEDLINE INDUSTRIES, INC.
URO170816CS
In Commercial Distribution

  • 40193489449663 ()
  • 10193489449662 ()

  • Catheter Gauge: 16 French
URO170816CS

  • Indwelling urethral catheterization kit, adult
CUSTOM PACK CB0M94R11 U OF IL
MEDTRONIC, INC.
CB0M94R11
Not in Commercial Distribution

  • 00643169842847 ()


  • Cardiopulmonary bypass system blood tubing set
AirLife™ U/Adapt-It Straight Adapter
AIRLIFE
004081
In Commercial Distribution

  • 10889483057957 ()
  • 10190752154193 ()
  • 30889483057951 ()
004081

  • Straight/elbow breathing circuit connector, single-use
AirLife™ U/Adapt-It Straight Connector
AIRLIFE
004204
In Commercial Distribution

  • 30889483571846 ()
  • 10889483571842 ()
004204

  • Straight/elbow breathing circuit connector, single-use
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