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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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N/A - D80737341221

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

N/A - D80737332321

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

N/A - D80737332221

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

N/A - D80737331321

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

N/A - D80737331221

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

N/A - D80737232101

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

Millennium - 00190776369026

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

  • 00190776369026 ()


  • Open-surgery dissector

Medline Industries, Inc. - 10884389897379

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 Aligners - 00190707101077

Absolute® Clear Retainers U/L
ORTHO ORGANIZERS, INC.
140-RT
In Commercial Distribution

  • 00190707101077 ()


  • Orthodontic progressive aligner

Reveal® Aligners - 00190707089764

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

  • 00190707089764 ()


  • Orthodontic progressive aligner

Elite® Mini-Twin® Brackets - 00190707085445

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

  • 00190707085445 ()


  • Orthodontic bracket, metal

Archwire - D972AMC2125UMAREU2

21x25 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC2125UMAREU
In Commercial Distribution

  • D972AMC2125UMAREU2 ()
  • D972AMC2125UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC2125UMAR2

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

  • D972AMC2125UMAR2 ()
  • D972AMC2125UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC2125LMAR2

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

  • D972AMC2125LMAR2 ()
  • AMC2125LMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC20UMAREU2

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

  • D972AMC20UMAREU2 ()
  • AMC20UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC20UMAR2

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

  • D972AMC20UMAR2 ()
  • AMC20UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC20LMAR2

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

  • D972AMC20LMAR2 ()
  • AMC20LMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC2020UMAREU2

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

  • D972AMC2020UMAREU2 ()
  • AMC2020UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC2020UMAR2

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

  • D972AMC2020UMAR2 ()
  • AMC2020UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC2020LMAR2

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

  • D972AMC2020LMAR2 ()
  • AMC2020LMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1925UMAREU2

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

  • D972AMC1925UMAREU2 ()
  • AMC1925UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC1925UMAR2

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

  • D972AMC1925UMAR2 ()
  • AMC1925UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1925LMAR2

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

  • D972AMC1925LMAR2 ()
  • AMC1925LMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1825LMAR2

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

  • D972AMC1825LMAR2 ()
  • AMC1825LMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1818UMAREU2

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

  • D972AMC1818UMAREU2 ()
  • AMC1818UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC1818UMAR2

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

  • D972AMC1818UMAR2 ()
  • AMC1818UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC16UMAREU2

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

  • D972AMC16UMAREU2 ()
  • AMC16UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC16UMAR2

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

  • D972AMC16UMAR2 ()
  • AMC16UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1622UMAREU2

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

  • D972AMC1622UMAREU2 ()
  • AMC1622UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC1622UMAR2

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

  • D972AMC1622UMAR2 ()
  • AMC1622UMAR0 ()


  • Orthodontic archwire
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