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 022/U&L6 XWD
DENTSPLY SIRONA ORTHODONTICS INC.
37-382-42
Not in Commercial Distribution

  • D80737382421 ()
  • D80737382420 ()
37-382-42

  • Orthodontic bracket, metal
TEW T 022/U&L6 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-382-32
Not in Commercial Distribution

  • D80737382321 ()
  • D80737382320 ()
37-382-32

  • Orthodontic bracket, metal
TEW T 018/U&L6 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-381-32
Not in Commercial Distribution

  • D80737381321 ()
  • D80737381320 ()
37-381-32

  • Orthodontic bracket, metal
TEW T 022/U&L4-5 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-342-32
Not in Commercial Distribution

  • D80737342321 ()
  • D80737342320 ()
37-342-32

  • Orthodontic bracket, metal
TEW T 022/U&L4-5 MED
DENTSPLY SIRONA ORTHODONTICS INC.
37-342-22
Not in Commercial Distribution

  • D80737342221 ()
  • D80737342220 ()
37-342-22

  • Orthodontic bracket, metal
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
RIVERSIDE TOTAL HIP U DRAPE 13
Cardinal Health 200, LLC
SOP32HP61H
In Commercial Distribution

  • 50887488133070 ()
  • 10887488133072 ()
SOP32HP61H

  • Orthopaedic surgical procedure kit, non-medicated, single-use
BIO-ACTIVE RC U FORM A 18X25
Gc Orthodontics America Inc.
74-A0U0-1825
In Commercial Distribution

  • E53574A0U018250 ()
  • E53574A0U018251 ()
74-A0U0-1825

  • Orthodontic archwire
BETA-TITAN FORM B 18X25 U (SO)
Gc Orthodontics America Inc.
73-B0U0-1825
In Commercial Distribution

  • E53573B0U018250 ()
  • E53573B0U018251 ()
73-B0U0-1825

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

  • 00190707101077 ()


  • Orthodontic progressive aligner
DB BRACKETS MINI 18 LAT U
LEONE SPA
F2282-901
In Commercial Distribution

  • 08033707040248 ()
F2282-901

  • Orthodontic bracket, metal
DB BRACKETS MINI 18 LAT U
LEONE SPA
F2282-01
In Commercial Distribution

  • 08033707040231 ()
F2282-01

  • Orthodontic bracket, metal
DB BRACKETS MINI 18 CEN U
LEONE SPA
F2281-901
In Commercial Distribution

  • 08033707040217 ()
F2281-901

  • Orthodontic bracket, metal
DB BRACKETS MINI 18 CEN U
LEONE SPA
F2281-01
In Commercial Distribution

  • 08033707040200 ()
F2281-01

  • Orthodontic bracket, metal
BRACKETS POS 18 CUS U/L
LEONE SPA
F2083F04
In Commercial Distribution

  • 08033707038375 ()
F2083F04

  • Orthodontic bracket, metal
BRACKETS POS 18 CUS U/R
LEONE SPA
F2083E04
In Commercial Distribution

  • 08033707038351 ()
F2083E04

  • Orthodontic bracket, metal
BRACKETS POS 18 LAT U/L
LEONE SPA
F2082D31
In Commercial Distribution

  • 08033707038283 ()
F2082D31

  • Orthodontic bracket, metal
BRACKETS POS 18 CEN U/R
LEONE SPA
F2081A21
In Commercial Distribution

  • 08033707038177 ()
F2081A21

  • Orthodontic bracket, metal
DB BRACKETS SING 18 ANT U
LEONE SPA
F2080-911
In Commercial Distribution

  • 08033707037897 ()
F2080-911

  • Orthodontic bracket, metal
DB BRACKETS SING 18 ANT U
LEONE SPA
F2080-11
In Commercial Distribution

  • 08033707037842 ()
F2080-11

  • Orthodontic bracket, metal
BRACKETS POS 22 CUS U/L
LEONE SPA
F2023F04
In Commercial Distribution

  • 08033707037231 ()
F2023F04

  • Orthodontic bracket, metal
BRACKETS POS 22 CUS U/R
LEONE SPA
F2023E04
In Commercial Distribution

  • 08033707037217 ()
F2023E04

  • Orthodontic bracket, metal
BRACKETS POS 22 LAT U/L
LEONE SPA
F2022D31
In Commercial Distribution

  • 08033707037149 ()
F2022D31

  • Orthodontic bracket, metal
BRACKETS POS 22 LAT U/R
LEONE SPA
F2022C31
In Commercial Distribution

  • 08033707037125 ()
F2022C31

  • Orthodontic bracket, metal
BRACKETS POS 22 CEN U/R
LEONE SPA
F2021A21
In Commercial Distribution

  • 08033707037033 ()
F2021A21

  • Orthodontic bracket, metal
AFFINITY MATTRESS U FOAM FOOT SECTION
CURBELL MEDICAL PRODUCTS, INC.
SM-AFFINITY-UFT
Not in Commercial Distribution

  • 00840828162746 ()
14575

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

  • 00190776369026 ()


  • Open-surgery dissector
U H S HEART PACK SC
MEDLINE INDUSTRIES, INC.
DYNJ07951I
In Commercial Distribution

  • 10884389626320 ()
DYNJ07951I

  • General surgical procedure kit, non-medicated, reusable
NEWBORN RESUSCIT KIT,U OF ALA
MEDLINE INDUSTRIES, INC.
DYK1060193NR
In Commercial Distribution

  • 10884389897379 ()
  • 40884389897370 ()
DYK1060193NR

  • General surgical procedure kit, non-medicated, single-use
AFFINITY MATTRESS U FOAM SEAT/BACK
CURBELL MEDICAL PRODUCTS, INC.
SM-AFFINITY-USB
Not in Commercial Distribution

  • 00840828162739 ()
14574

  • Orthopaedic bed mattress
ANAXDENT PMMA BLANK U CLEAR 20mm
UNION DENTAL SA
PMMA Blank U CLEAR 20mm
Not in Commercial Distribution

  • 08435288418018 ()
18100020

  • Temporary dental crown/bridge
ANAXDENT PMMA BLANK U CLEAR 16mm
UNION DENTAL SA
PMMA Blank U CLEAR 16mm
Not in Commercial Distribution

  • 08435288418001 ()
18100030

  • Temporary dental crown/bridge
MTO HARNESS REPLACEMT PS3500EP C/U
Smith & Nephew, Inc.
7204890
Not in Commercial Distribution

  • 03596010250650 ()
7204890

  • Arthroscopic shaver system, electrically-powered
SE PROBE U OF MICH O
NORDENT MANUFACTURING INC
PUMO
In Commercial Distribution

  • 00840018606494 ()


  • Periodontal probe, reusable
BDS CHEEK RETRACTOR U OF MINN
NORDENT MANUFACTURING INC
CRM/BH
In Commercial Distribution

  • 00840018603011 ()


  • Hand-held dental retractor
ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
494-1410
Not in Commercial Distribution

  • 00889989007206 ()
  • 10889989007203 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
495-1411
Not in Commercial Distribution

  • 00889989007466 ()
  • 10889989007463 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
495-1410
Not in Commercial Distribution

  • 00889989007459 ()
  • 10889989007456 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
495-0411
Not in Commercial Distribution

  • 00889989007398 ()
  • 10889989007395 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
495-0410
Not in Commercial Distribution

  • 00889989007381 ()
  • 10889989007388 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
494-1411
Not in Commercial Distribution

  • 00889989007213 ()
  • 10889989007210 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
494-0411
Not in Commercial Distribution

  • 00889989007084 ()
  • 10889989007081 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use
ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
494-0410
Not in Commercial Distribution

  • 00889989007077 ()
  • 10889989007074 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use
SE SCALER U OF TEXAS 106
NORDENT MANUFACTURING INC
SCUT106
In Commercial Distribution

  • 00840018610798 ()


  • Manual dental scaler, reusable
SE SCALERS U OF TEXAS 103
NORDENT MANUFACTURING INC
SCUT103
In Commercial Distribution

  • 00840018610781 ()


  • Manual dental scaler, reusable
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