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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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
DE SCALER U of TEX 103-106
NORDENT MANUFACTURING INC
SC103-106
In Commercial Distribution

  • 00840018608313 ()


  • Manual dental scaler, reusable
CALIBRA BICUSPID BANDS UPPER KIT U
LEONE SPA
E5100-92
In Commercial Distribution

  • 08033707024897 ()
E5100-92

  • Orthodontic metal band
DB BRACKETS MINI 22 LAT U
LEONE SPA
F2222-901
In Commercial Distribution

  • 08033707040101 ()
F2222-901

  • Orthodontic bracket, metal
DB BRACKETS MINI 22 LAT U
LEONE SPA
F2222-01
In Commercial Distribution

  • 08033707040095 ()
F2222-01

  • Orthodontic bracket, metal
DB BRACKETS MINI 22 CEN U
LEONE SPA
F2221-901
In Commercial Distribution

  • 08033707040071 ()
F2221-901

  • Orthodontic bracket, metal
DB BRACKETS MINI 22 CEN U
LEONE SPA
F2221-01
In Commercial Distribution

  • 08033707040064 ()
F2221-01

  • Orthodontic bracket, metal
BRACKETS POS 18 LAT U/R
LEONE SPA
F2082C31
In Commercial Distribution

  • 08033707038269 ()
F2082C31

  • Orthodontic bracket, metal
BRACKETS POS 18 CEN U/L
LEONE SPA
F2081B21
In Commercial Distribution

  • 08033707038184 ()
F2081B21

  • Orthodontic bracket, metal
BRACKETS POS 22 CEN U/L
LEONE SPA
F2021B21
In Commercial Distribution

  • 08033707037040 ()
F2021B21

  • Orthodontic bracket, metal
DB BRACKETS SING 22 ANT U
LEONE SPA
F2020-911
In Commercial Distribution

  • 08033707036760 ()
F2020-911

  • Orthodontic bracket, metal
DB BRACKETS SING 22 ANT U
LEONE SPA
F2020-11
In Commercial Distribution

  • 08033707036715 ()
F2020-11

  • Orthodontic bracket, metal
INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
79-ACU4-2020
In Commercial Distribution

  • D78879ACU420200 ()
  • D78879ACU420201 ()
79-ACU4-2020

  • Orthodontic archwire
SS RC FORM A 18X25 U
Gc Orthodontics America Inc.
79-A2U0-1825
In Commercial Distribution

  • D78879A2U018250 ()
  • D78879A2U018251 ()
79-A2U0-1825

  • Orthodontic archwire
SS RC FORM A 16X16 U
Gc Orthodontics America Inc.
79-A2U0-1616
In Commercial Distribution

  • D78879A2U016160 ()
  • D78879A2U016161 ()
79-A2U0-1616

  • Orthodontic archwire
BIO-ACTIVE RC U FORM B 18X25
Gc Orthodontics America Inc.
74-B0U0-1825
In Commercial Distribution

  • D78874B0U018250 ()
  • D78874B0U018251 ()
74-B0U0-1825

  • Orthodontic archwire
INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
71-C3U0-0018
In Commercial Distribution

  • D78871C3U000180 ()
  • D78871C3U000181 ()
71-C3U0-0018

  • Orthodontic archwire
INITIALLOY FORM C 014 U HEAVY
Gc Orthodontics America Inc.
71-C3U0-0014
In Commercial Distribution

  • D78871C3U000140 ()
  • D78871C3U000141 ()
71-C3U0-0014

  • Orthodontic archwire
LMI BID VSLOT U/L7-7 HK3
Gc Orthodontics America Inc.
31-BID3-3169
In Commercial Distribution

  • D78831BID331691 ()
31-BID3-3169

  • Orthodontic bracket, metal
NI-TEK DIMPLE ARCHWIRE U/.018 PK10
DARBY DENTAL SUPPLY, LLC
0800018
In Commercial Distribution

  • 00889813056639 ()
  • 00889813056646 ()
0800018

  • Orthodontic archwire
NI-TEK DIMPLE ACHWIRE U/.016 PK10
DARBY DENTAL SUPPLY, LLC
0800016
In Commercial Distribution

  • 00889813056615 ()
  • 00889813056622 ()
0800016

  • Orthodontic archwire
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