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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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TEW 022/U&L6 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-282-32
Not in Commercial Distribution

  • D80737282321 ()
  • D80737282320 ()
37-282-32

  • Orthodontic bracket, metal
TEW 018/U&L6 XWD
DENTSPLY SIRONA ORTHODONTICS INC.
37-281-42
Not in Commercial Distribution

  • D80737281421 ()
  • D80737281420 ()
37-281-42

  • Orthodontic bracket, metal
TEW 018/U&L6 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-281-32
Not in Commercial Distribution

  • D80737281321 ()
  • D80737281320 ()
37-281-32

  • Orthodontic bracket, metal
TEW 022/U&L4-5 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-242-32
Not in Commercial Distribution

  • D80737242321 ()
  • D80737242320 ()
37-242-32

  • Orthodontic bracket, metal
TEW 022/U&L4-5 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-242-22
Not in Commercial Distribution

  • D80737242221 ()
  • D80737242220 ()
37-242-22

  • Orthodontic bracket, metal
TEW 022/U&L4-5 NAR
DENTSPLY SIRONA ORTHODONTICS INC.
37-242-12
Not in Commercial Distribution

  • D80737242121 ()
  • D80737242120 ()
37-242-12

  • Orthodontic bracket, metal
TEW 018/U&L4-5 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-241-22
Not in Commercial Distribution

  • D80737241221 ()
  • D80737241220 ()
37-241-22

  • Orthodontic bracket, metal
TEW 018/U&L4-5 NAR
DENTSPLY SIRONA ORTHODONTICS INC.
37-241-12
Not in Commercial Distribution

  • D80737241121 ()
  • D80737241120 ()
37-241-12

  • Orthodontic bracket, metal
TEW 022/U&L3 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-232-32
Not in Commercial Distribution

  • D80737232321 ()
  • D80737232320 ()
37-232-32

  • Orthodontic bracket, metal
TEW 022/U&L3 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-232-22
Not in Commercial Distribution

  • D80737232221 ()
  • D80737232220 ()
37-232-22

  • Orthodontic bracket, metal
TEW 018/U&L3 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-231-32
Not in Commercial Distribution

  • D80737231321 ()
  • D80737231320 ()
37-231-32

  • Orthodontic bracket, metal
TEW 018/U&L3 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-231-22
Not in Commercial Distribution

  • D80737231221 ()
  • D80737231220 ()
37-231-22

  • Orthodontic bracket, metal
TEW 018/U&L3 NAR
DENTSPLY SIRONA ORTHODONTICS INC.
37-231-12
Not in Commercial Distribution

  • D80737231121 ()
  • D80737231120 ()
37-231-12

  • Orthodontic bracket, metal
SEW 022/U&L4-5 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-142-32
Not in Commercial Distribution

  • D80737142321 ()
  • D80737142320 ()
37-142-32

  • Orthodontic bracket, metal
SEW 022/U&L4-5 NAR
DENTSPLY SIRONA ORTHODONTICS INC.
37-142-12
Not in Commercial Distribution

  • D80737142121 ()
  • D80737142120 ()
37-142-12

  • Orthodontic bracket, metal
SEW 022/U&L3 XWD
DENTSPLY SIRONA ORTHODONTICS INC.
37-132-42
Not in Commercial Distribution

  • D80737132421 ()
  • D80737132420 ()
37-132-42

  • Orthodontic bracket, metal
SEW 022/U&L3 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-132-32
Not in Commercial Distribution

  • D80737132321 ()
  • D80737132320 ()
37-132-32

  • Orthodontic bracket, metal
SEW 018/U&L3 NAR
DENTSPLY SIRONA ORTHODONTICS INC.
37-131-12
Not in Commercial Distribution

  • D80737131121 ()
  • D80737131120 ()
37-131-12

  • Orthodontic bracket, metal
U/L 5-5 0.56mm (0.022")
TP ORTHODONTICS INC
290-600
In Commercial Distribution

  • 00192029021323 ()


  • Orthodontic bracket, metal
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI199
In Commercial Distribution

  • 50888439954744 ()
  • 10888439954746 ()
SAN56PI199

  • General surgical procedure kit, non-medicated, single-use
U OF UTAH VASCULAR TRAY
Cardinal Health 200, LLC
SCV56VT192
In Commercial Distribution

  • 50888439975800 ()
  • 10888439975802 ()
SCV56VT192

  • Cardiothoracic surgical procedure kit, medicated, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI111
In Commercial Distribution

  • 50888439993293 ()
  • 10888439993295 ()
SAN56PI111

  • General surgical procedure kit, non-medicated, single-use
AWL EX0815021 U JOINT SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0815021
In Commercial Distribution

  • 00643169693593 ()


  • Bone awl, reusable
21x25 Premium NiTi - Euro - U
Acme Monaco Corporation
AMC2125UNITIEU
In Commercial Distribution

  • D972AMC2125UNITIEU2 ()
  • D972AMC2125UNITIEU0 ()


  • Orthodontic archwire
21x25 Premium NiTi - Nat - U
Acme Monaco Corporation
AMC2125UNITI
In Commercial Distribution

  • D972AMC2125UNITI2 ()
  • D972AMC2125UNITI0 ()


  • Orthodontic archwire
21x25 Stainless Steel - Nat - U
Acme Monaco Corporation
AMC2125UNAT
In Commercial Distribution

  • D972AMC2125UNAT2 ()
  • D972AMC2125UNAT0 ()


  • Orthodontic archwire
21x25 Stainless Steel - Euro - U
Acme Monaco Corporation
AMC2125UEUST
In Commercial Distribution

  • D972AMC2125UEUST2 ()
  • AMC2125UEUST0 ()


  • Orthodontic archwire
.020 Premium NiTi - Euro - U
Acme Monaco Corporation
AMC20UNITIEU
In Commercial Distribution

  • D972AMC20UNITIEU2 ()
  • AMC20UNITIEU0 ()


  • Orthodontic archwire
.020 Premium NiTi - Nat - U
Acme Monaco Corporation
AMC20UNITI
In Commercial Distribution

  • D972AMC20UNITI2 ()
  • AMC20UNITI0 ()


  • Orthodontic archwire
.020 Stainless Steel - Nat - U
Acme Monaco Corporation
AMC20UNAT
In Commercial Distribution

  • D972AMC20UNAT2 ()
  • AMC20UNAT0 ()


  • Orthodontic archwire
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