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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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Support sleeve with distal protector - ENOU1737NOU9

Support sleeve with distal protector for working channel 4.1 mm
Nouvag AG
1737NOU
In Commercial Distribution

  • ENOU1737NOU9 ()


  • Orthopaedic bur, reusable

SPK10831 Jackson Kit with ProneSafe - 00787551004939

SPK10831 Jackson Kit with ProneSafe
XODUS MEDICAL, INC.
SPK10831
In Commercial Distribution

  • 20787551004933 ()
  • 00787551004939 ()
SPK10831

  • Operating table patient positioning set, single-use

SPK10740 ProAxis Jackson with ProneSafe - 00787551003642

SPK10740 ProAxis Jackson with ProneSafe
XODUS MEDICAL, INC.
SPK10740
In Commercial Distribution

  • 20787551003646 ()
  • 00787551003642 ()
SPK10740

  • Operating table patient positioning set, single-use

Hemorrhoidal Multi-Band Ligator with Anoscope - 06951862291560

This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Changzhou Health Microport Medical Device Co., Ltd
HM/601-5-B
In Commercial Distribution

  • 06951862291560 ()


  • Haemorrhoid ligation set

Hemorrhoidal Multi-Band Ligator with Anoscope - 06951862291539

This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Changzhou Health Microport Medical Device Co., Ltd
HM/601-3-A
In Commercial Distribution

  • 06951862291539 ()


  • Haemorrhoid ligation set

9mm Nozzle With Nozzle Extruder - 15060238201718

9mm Nozzle With Nozzle Extruder
SUMMIT MEDICAL LIMITED
N700
In Commercial Distribution

  • 25060238201715 ()
  • 15060238201718 ()
N700

  • Orthopaedic cement injection cannula

Arthrography Tray with Safety Devices - 00886333220687

Arthrography Tray with Safety Devices
ARGON MEDICAL DEVICES, INC.
A4325SP
Not in Commercial Distribution

  • 20886333220681 ()
  • 00886333220687 ()
A4325SP

  • Arthrogram kit

Vessel Dilator with Feathered Tip - 00886333210466

Vessel Dilator with Feathered Tip 7 French
ARGON MEDICAL DEVICES, INC.
392357
Not in Commercial Distribution

  • 10886333210463 ()
  • 00886333210466 ()

  • 7 French
392357

  • Fascial tissue dilator, single-use

Vessel Dilator with Feathered Tip - 00886333210459

Vessel Dilator with Feathered Tip 6 French
ARGON MEDICAL DEVICES, INC.
392356
Not in Commercial Distribution

  • 10886333210456 ()
  • 00886333210459 ()

  • 6 French
392356

  • Fascial tissue dilator, single-use

Vessel Dilator with Feathered Tip - 00886333210442

Vessel Dilator with Feathered Tip 5 French
ARGON MEDICAL DEVICES, INC.
392355
Not in Commercial Distribution

  • 10886333210449 ()
  • 00886333210442 ()

  • 5 French
392355

  • Fascial tissue dilator, single-use

MC 300 Nebulizer with Mouthpiece - 00762860055506

MC 300 Nebulizer with Mouthpiece
Trudell Medical International
105550
In Commercial Distribution

  • 00762860055506 ()
  • 10762860055503 ()
  • 62860105550028 ()


  • Nebulizing system delivery set, reusable

LATITUDE® Communicator with Wand - 00802526480485

LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526480485 ()


  • Multi-hole nuclear medicine system collimator, high-energy

LATITUDE® Communicator with Wand - 00802526580727

LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526580727 ()


  • Patient monitoring modem

Buck's Traction with Heel Hole - 00810006681581

Buck's Traction with Heel Hole
PRIMO INC
BT02-12
In Commercial Distribution

  • 00810006682991 ()
  • 00810006681581 ()
BT02-12

  • Freestanding patient positioner, single-use

Introducer set with hemostatic valve - 20889942000361

Introducer set with hemostatic valve, 9F
Oscor Inc.
DYNJINTROL9
Not in Commercial Distribution

  • 20889942000361 ()
  • 10889942000364 ()

  • Sheath Length 23 cm
  • Needle 18 G
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Lumen/Inner Diameter: 3 Millimeter
DYNJINTROL9

  • Vascular catheter introduction set, nonimplantable

Introducer set with hemostatic valve - 20889942000354

Introducer set with hemostatic valve, 8F
Oscor Inc.
DYNJINTROL8
Not in Commercial Distribution

  • 20889942000354 ()
  • 10889942000357 ()

  • Syringe 10 cc
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Dilator Length 28 cm
  • Lumen/Inner Diameter: 2.7 Millimeter
  • Sheath Length 23 cm
  • Needle 18 G
DYNJINTROL8

  • Vascular catheter introduction set, nonimplantable

Introducer set with hemostatic valve - 20889942000347

Introducer set with hemostatic valve, 7F
Oscor Inc.
DYNJINTROL7
Not in Commercial Distribution

  • 20889942000347 ()
  • 10889942000340 ()

  • Lumen/Inner Diameter: 2.4 Millimeter
  • Needle 18 G
  • Sheath Length 23 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Dilator Length 28 cm
DYNJINTROL7

  • Vascular catheter introduction set, nonimplantable

Introducer set with hemostatic valve - 20889942000286

Introducer set with hemostatic valve, 12F
Oscor Inc.
DYNJINTROL12
Not in Commercial Distribution

  • 20889942000286 ()
  • 10889942000289 ()

  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 4 Millimeter
  • Needle 18 G
  • Dilator Length 28 cm
  • Sheath Length 23 cm
  • Syringe 10 cc
DYNJINTROL12

  • Vascular catheter introduction set, nonimplantable

Introducer set with hemostatic valve - 20889942000279

Introducer set with hemostatic valve, 11F
Oscor Inc.
DYNJINTROL11
Not in Commercial Distribution

  • 20889942000279 ()
  • 10889942000272 ()

  • Syringe 10 cc
  • Lumen/Inner Diameter: 3.7 Millimeter
  • Needle 18 G
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Sheath Length 23 cm
  • Dilator Length 28 cm
DYNJINTROL11

  • Vascular catheter introduction set, nonimplantable

Introducer set with hemostatic valve - 20889942000217

Introducer set with hemostatic valve, 10F
Oscor Inc.
DYNJINTROL10
Not in Commercial Distribution

  • 20889942000217 ()
  • 10889942000210 ()

  • Sheath Length 23 cm
  • Syringe 10 cc
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 3.4 Millimeter
  • Needle 18 G
DYNJINTROL10

  • Vascular catheter introduction set, nonimplantable

Quinns Advantage Medium with HEPES - 20888937819100

Quinns Advantage Medium with HEPES (Ca/Mg free). 4x12 ml
Origio A/S
ART-4100
In Commercial Distribution

  • 20888937819100 ()
  • 00888937819083 ()


  • IVF medium

Dual Dispersive Electrodes with Connector - 20888937014284

Dual Dispersive Electrodes with Connector, 1 Box of 10
Coopersurgical, Inc.
LP-50-201
In Commercial Distribution

  • 20888937014284 ()


  • Electrosurgical system generator

Enhance Sperm Wash with Gentamicin - 00805360016841

1-(100ml) Sperm Wash Modified HTF Medium w/Gentamicin
VITROLIFE INC.
15261
In Commercial Distribution

  • 00805360016841 ()

  • Total Volume: 100 Milliliter


  • Spermatozoa/semen motility medium supplement

Straight abutment wide with shoulder - 07290018434604

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
4mm
In Commercial Distribution

  • 07290018434604 ()
SAW4

  • Dental implant system

Straight abutment wide with shoulder - 07290018434598

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
3mm
In Commercial Distribution

  • 07290018434598 ()
SAW3

  • Dental implant system

Straight abutment wide with shoulder - 07290018434581

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
2mm
In Commercial Distribution

  • 07290018434581 ()
SAW2

  • Dental implant system

Straight abutment wide with shoulder - 07290018434574

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
1mm
In Commercial Distribution

  • 07290018434574 ()
SAW1

  • Dental implant system

RATCHET HANDLE WITH AO CONNECT - 00810012485760

No Description
BIOPRO, INC.
22293
In Commercial Distribution

  • 00810012485760 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Vial Adapter 20mm with silicon - 07290108241099

No Description
WEST PHARMA. SERVICES IL, . LTD
8000016
In Commercial Distribution

  • 07290108241099 ()


  • Vial/bottle adaptor, hermetic

AP403-01 - MICROBORE WITH NON-VENTED SPIKE - 17290109159192

No Description
EITAN MEDICAL LTD
12003-000-0013
In Commercial Distribution

  • 27290109159199 ()
  • 17290109159192 ()
12003-000-0013

  • Electric infusion pump administration set, single-use

Mini Cradle with Splitter - US - 17290109154029

No Description
EITAN MEDICAL LTD
17000-026-0007
In Commercial Distribution

  • 27290109154026 ()
  • 17290109154029 ()
  • 07290109154022 ()
  • 27290109154439 ()
17000-026-0007

  • Frame/rail/pole device holder

Mini Cradle with Splitter- US - 17290109150113

No Description
EITAN MEDICAL LTD
17000-026-0007
In Commercial Distribution

  • 07290109150000 ()
  • 17290109150014 ()
  • 27290109150110 ()
  • 17290109150113 ()
17000-026-0007

  • Intravenous pole multi-outlet holder

Mini Cradle with Splitter- US - 17290109150014

No Description
EITAN MEDICAL LTD
17000-026-0007
Not in Commercial Distribution

  • 07290109150000 ()
  • 27290109150011 ()
  • 17290109150014 ()
17000-026-0007

  • Intravenous pole multi-outlet holder

AP403-01 MICROBORE WITH NON-VENTED SPIKE - 17290109150441

No Description
EITAN MEDICAL LTD
12003-000-0020
In Commercial Distribution

  • 27290109150448 ()
  • 17290109150441 ()
12003-000-0020

  • Electric infusion pump administration set, single-use

Telemetry Transmitter(TD60 with Resp) - 06944904093413

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-047566-00
In Commercial Distribution

  • 06944904093413 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

IBP upgrd pkg/with accssry - 06944904085982

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-030583-00
In Commercial Distribution

  • 06944904085982 ()


  • Patient monitoring system module, blood pressure, invasive

CO upgrd pkg/with accssry - 06944904085975

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-030582-00
In Commercial Distribution

  • 06944904085975 ()


  • Patient monitoring system module, cardiac output

Receiver Cabinet with 4 Channels - 06944904055398

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-028187-00
In Commercial Distribution

  • 06944904055398 ()
115-028187-00

  • Multiple-patient intensive/general healthcare physiologic monitoring system

Endotracheal Tube with Evacuation Lumen - 06944932784147

PU Cuff 9.0 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04904F
In Commercial Distribution

  • 16944932784144 ()
  • 06944932784147 ()
  • 26944932784141 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932784123

PU Cuff 8.5 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04854F
In Commercial Distribution

  • 16944932784120 ()
  • 06944932784123 ()
  • 26944932784127 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932784109

PU Cuff 8.0 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04804F
In Commercial Distribution

  • 16944932784106 ()
  • 06944932784109 ()
  • 26944932784103 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932784086

PU Cuff 7.5 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04754F
In Commercial Distribution

  • 16944932784083 ()
  • 06944932784086 ()
  • 26944932784080 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932784062

PU Cuff 7.0 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04704F
In Commercial Distribution

  • 16944932784069 ()
  • 06944932784062 ()
  • 26944932784066 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932784048

PU Cuff 6.5 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04654F
In Commercial Distribution

  • 16944932784045 ()
  • 06944932784048 ()
  • 26944932784042 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932784024

PU Cuff 6.0 DEHP FREE
Well Lead Medical Co.,Ltd
A01G04604F
In Commercial Distribution

  • 16944932784021 ()
  • 06944932784024 ()
  • 26944932784028 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932774926

PVC DEHP Free Cuff 9.0
Well Lead Medical Co.,Ltd
A01F01901F
In Commercial Distribution

  • 16944932774923 ()
  • 06944932774926 ()
  • 26944932774920 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932774902

PVC DEHP Free Cuff 8.5
Well Lead Medical Co.,Ltd
A01F01851F
In Commercial Distribution

  • 16944932774909 ()
  • 06944932774902 ()
  • 26944932774906 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932774889

PVC DEHP Free Cuff 8.0
Well Lead Medical Co.,Ltd
A01F01801F
In Commercial Distribution

  • 16944932774886 ()
  • 06944932774889 ()
  • 26944932774883 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932774865

PVC DEHP Free Cuff 7.5
Well Lead Medical Co.,Ltd
A01F01751F
In Commercial Distribution

  • 16944932774862 ()
  • 06944932774865 ()
  • 26944932774869 ()


  • Basic endotracheal tube, single-use

Endotracheal Tube with Evacuation Lumen - 06944932774841

PVC DEHP Free Cuff 7.0
Well Lead Medical Co.,Ltd
A01F01701F
In Commercial Distribution

  • 16944932774848 ()
  • 06944932774841 ()
  • 26944932774845 ()


  • Basic endotracheal tube, single-use
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