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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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AccuThrive® - 00843382105211

AccuThrive #22 Surgical Blade SS Microcoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 20843382105215 ()
  • 00843382105211 ()
AVBL-1071-0000

  • Manual scalpel blade, single-use

AccuThrive® - 00843382105204

AccuThrive #20 Surgical Blade SS Microcoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382105201 ()
  • 00843382105204 ()
AVBL-1051-0000

  • Manual scalpel blade, single-use

AccuThrive® - 00843382105198

AccuThrive #15C Surgical Blade SS MicroCoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382105195 ()
  • 00843382105198 ()
AVBL-1041-0000

  • Manual scalpel blade, single-use

AccuThrive® - 00843382104245

AccuThrive #11 Surgical Blade SS MicroCoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382104242 ()
  • 00843382104245 ()
AVBL-1021-0000

  • Manual scalpel blade, single-use

iCE Surgical Light - 00684706001211

S3 300DT SGL CA DUAL CA 1150 1000 850 RS 3P 30M MH1
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001211 ()
C33SDB432R31

  • Operating room light

AccuThrive® - 00843382104085

AccuThrive Vitality Microtome Blade High Profile SS Microcoat 500BL/CA (50BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104082 ()
  • 00843382104085 ()
AVBL-2021-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104078

AccuThrive Vitality Microtome Blade High Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104075 ()
  • 00843382104078 ()
AVBL-2020-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104061

AccuThrive Longevity Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104068 ()
  • 00843382104061 ()
AVBL-2011-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104047

AccuThrive Longevity Microtome Blade High Profile Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104044 ()
  • 00843382104047 ()
AVBL-2009-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104030

AccuThrive Longevity Microtome Blade High Profile SS Microcoat, 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104037 ()
  • 00843382104030 ()
AVBL-2008-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382103972

AccuThrive Agility Microtome Blade High Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382103979 ()
  • 00843382103972 ()
AVBL-2004-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104290

AccuThrive Vitality Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104297 ()
  • 00843382104290 ()
AVBL-2023-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104283

AccuThrive Vitality Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104280 ()
  • 00843382104283 ()
AVBL-2022-0000

  • Microtome blade IVD, single-use

iCE Surgical Light - 00684706001068

S3 300 DT sgl CA dual CA 1300 1150 1000 3x 9p DY SL-3M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001068 ()
C33SDB543555

  • Operating room light

iCE Surgical Light - 00684706001785

S3 300 DT 2xSgl CA 1xDual CA 1150,1000,850,1150, 2x Sgl MH, 2x LCH SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001785 ()
C33SDS43241441

  • Operating room light

iCE Surgical Light - 00684706000979

Series 3 400DT sgl CA dual CA 1300,1150,1000 DUAL YOK 30M 30M MH1(G2)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706000979 ()
C34SDB543733

  • Operating room light

SMARTABLATE SCom. Recording-/CARTO® Cable - 04260166371352

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m
Stockert GmbH
M490021
In Commercial Distribution

  • 04260166371352 ()


  • Electrical-only medical device connection cable, reusable

SMARTABLATE-SCom. Recording-/CARTO® Cable - 04260166371345

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable

OrthoFlex - 00190730002532

OrtFlx Com McLaughlin 022 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-874
In Commercial Distribution

  • 00190730002532 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002525

OrtFlx Com McLaughlin 022 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-873
In Commercial Distribution

  • 00190730002525 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002495

OrtFlx Com McLaughlin 022 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-864
In Commercial Distribution

  • 00190730002495 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002488

OrtFlx Com McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-863
In Commercial Distribution

  • 00190730002488 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002228

OrtFlx Com McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-812
In Commercial Distribution

  • 00190730002228 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002204

OrtFlx Com McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-811
In Commercial Distribution

  • 00190730002204 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002181

OrtFlx Com McLaughlin 022 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-802
In Commercial Distribution

  • 00190730002181 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002167

OrtFlx Com McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-801
In Commercial Distribution

  • 00190730002167 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002150

OrtFlx Com McLaughlin 018 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-774
In Commercial Distribution

  • 00190730002150 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002143

OrtFlx Com McLaughlin 018 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-773
In Commercial Distribution

  • 00190730002143 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002112

OrtFlx Com McLaughlin 018 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-764
In Commercial Distribution

  • 00190730002112 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002105

OrtFlx Com McLaughlin 018 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-763
In Commercial Distribution

  • 00190730002105 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001849

OrtFlx Com McLaughlin 018 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-712
In Commercial Distribution

  • 00190730001849 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001825

OrtFlx Com McLaughlin 018 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-711
In Commercial Distribution

  • 00190730001825 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001801

OrtFlx Com McLaughlin 018 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-702
In Commercial Distribution

  • 00190730001801 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001788

OrtFlx Com McLaughlin 018 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-701
In Commercial Distribution

  • 00190730001788 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000651

Avalon Com McLaughlin 022 LL4 Rx -12° Tor. +2° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-864
Not in Commercial Distribution

  • 00190730000651 ()


  • Orthodontic bracket, plastic, single-use

NORDENT MANUFACTURING INC - 00840018606265

ENCO EXPLORER 16 .125 TIPS (CA
NORDENT MANUFACTURING INC
EX16-GB
In Commercial Distribution

  • 00840018606265 ()


  • Dental surgical probe, reusable

ZILMASTER - E23506710

ZILMASTER FINE CA MINI POINT 3
SHOFU DENTAL CORPORATION
0671
In Commercial Distribution

  • E23506710 ()
0671

  • Dental abrasive point, reusable

ZILMASTER - E23506610

ZILMASTER COARSE CA MINI PT 3P
SHOFU DENTAL CORPORATION
0661
In Commercial Distribution

  • E23506610 ()
0661

  • Dental abrasive point, reusable

Curaplex - 00810071637285

HUMIDIFIER,DRY,HIGH FLOW,10/CA
BOUND TREE MEDICAL, LLC
301-P3050
In Commercial Distribution

  • 00810071638008 ()
  • 00810071637285 ()
301-P3050EA

  • Non-heated respiratory humidifier

Curaplex - 00810071631214

MASK,OX,ADL,7',50/CA
BOUND TREE MEDICAL, LLC
301-180EA
In Commercial Distribution

  • 00810071630811 ()
  • 00810071631214 ()
301-180EA

  • Rebreathing oxygen face mask

Curaplex - 00810071631047

CANNULA,ADL,SOFT,25'*,25/CA
BOUND TREE MEDICAL, LLC
301-115
In Commercial Distribution

  • 00810071630644 ()
  • 00810071631047 ()
301-115

  • Tracheostomy tube cannula, single-use

Curaplex - 00810071631030

CANNULA,ADL,SOFT,14'*,50/CA
BOUND TREE MEDICAL, LLC
301-114
In Commercial Distribution

  • 00810071630637 ()
  • 00810071631030 ()
301-114

  • Tracheostomy tube cannula, single-use

Curaplex - 00810071630989

CANNULA,ADL,25FT,FLARED,25/CA
BOUND TREE MEDICAL, LLC
301-104
In Commercial Distribution

  • 00810071630583 ()
  • 00810071630989 ()
301-104

  • Tracheostomy tube cannula, single-use

Curaplex - 00810071630965

CANNULA,ADL,7',FLARED,50/CA
BOUND TREE MEDICAL, LLC
301-100EA
In Commercial Distribution

  • 00810071630569 ()
  • 00810071630965 ()
301-100EA

  • Tracheostomy tube cannula, single-use

CHATTANOOGA - 00888912340793

DURA-STICK BG 2" SQ 40/CA
DJO, LLC
42176
In Commercial Distribution

  • 00888912340793 ()


  • Transcutaneous electrical stimulation electrode, single-use

Astra Tech Implant System® - 07392532002076

Hex CA Driver Long, 35 mm
Dentsply Implants Manufacturing GmbH
22549
In Commercial Distribution

  • 07392532002076 ()
22549

  • Surgical screwdriver, reusable

Astra Tech Implant System® - 07392532002069

Hex CA Driver Short, 24 mm
Dentsply Implants Manufacturing GmbH
22548
In Commercial Distribution

  • 07392532002069 ()
22548

  • Surgical screwdriver, reusable

Arthrex® - 00888867229778

Revers Trial CA Head, 56/24
ARTHREX, INC.
AR-9556-24RCAT
Not in Commercial Distribution

  • 00888867229778 ()
  • M150AR955624RCAT0 ()
AR-9556-24RCAT

  • Reverse shoulder head prosthesis trial

PHONAK - 07613389355994

KS 9.0 Kit Monaural CA (beige)
Sonova AG
051-0115-H056
In Commercial Distribution

  • 07613389355994 ()
051-0115-H056

  • Air-conduction hearing aid, receiver-in-canal

PHONAK - 07613389355987

KS 9.0 Kit Monaural CA (stone)
Sonova AG
051-0115-D056
In Commercial Distribution

  • 07613389355987 ()
051-0115-D056

  • Air-conduction hearing aid, receiver-in-canal
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