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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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MINI3000 LED - 04053755158812

No Description
Heine Optotechnik GmbH & Co. KG
2,5 V WITH SCALE
In Commercial Distribution

  • 04053755158812 ()
D-008.78.108

  • Dermatoscope, optical

MINI3000 - 04053755124909

No Description
Heine Optotechnik GmbH & Co. KG
2,5 V WITH SCALE
In Commercial Distribution

  • 04053755124909 ()
D-001.78.108

  • Dermatoscope, optical

REMstar - 00606959036888

REMstar with Humidifier, International
Respironics, Inc.
REMstar, with Humidifier, INTL
Not in Commercial Distribution

  • 00606959036888 ()
IN171H

  • Heated respiratory humidifier
  • Home CPAP unit

All Soft Ureteral Stent - 7F, 24cm with Suture - 00812261010694

7F, 24cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 24cm with Suture
In Commercial Distribution

  • 10812261010691 ()
  • 00812261010694 ()
SOT 7/24-S

  • Polymeric ureteral stent

CAM - 00840682125291

CAM CONNECT 14 WITH BARCODE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Connect 14 with Barcode
In Commercial Distribution

  • 00840682125291 ()
2091685-001

  • Electrocardiograph, professional, multichannel

All Soft Ureteral Stent - 7F, 26cm with Suture - 00812261015279

All Soft Ureteral Stent - 7F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 26cm with Suture
In Commercial Distribution

  • 10812261015276 ()
  • 00812261015279 ()
SOT 7/26-S

  • Polymeric ureteral stent

All Soft Ureteral Stent - 6F, 26cm with Suture - 00812261013756

All Soft Ureteral Stent - 6F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
6F, 26cm with Suture
In Commercial Distribution

  • 10812261013753 ()
  • 00812261013756 ()
SOT 6/26-S

  • Polymeric ureteral stent

All Soft Ureteral Stent - 7F, 22cm with Suture - 00812261013213

7F, 22cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 22cm with Suture
In Commercial Distribution

  • 10812261013210 ()
  • 00812261013213 ()
SOT 7/22-S

  • Polymeric ureteral stent

Siemens - 57117810000743

Siemens UNITY 3 WITH INSERTS
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERTS
Not in Commercial Distribution

  • 57117810000743 ()
10824331

  • Audiometric/hearing aid tester

Iron Intern - 00810118341014

GFO21 Deaver with Fiber-optic
Automated Medical Products Corp.
GFO21 Deaver with Fiber-optic
In Commercial Distribution

  • 00810118341014 ()
GFO021

  • Surgical retractor/retraction system blade, reusable

Iron Intern - 00810118341007

GFO20 Deaver with Fiber-optic
Automated Medical Products Corp.
GFO20 Deaver with Fiber-optic
In Commercial Distribution

  • 00810118341007 ()
GFO020

  • Surgical retractor/retraction system blade, reusable

Iron Intern - 00810118340963

GFO80 "Sweetlips" with Fiber-optic
Automated Medical Products Corp.
GFO80 "Sweetlips" with Fiber-optic
In Commercial Distribution

  • 00810118340963 ()
GFO080

  • Surgical retractor/retraction system blade, reusable

Iron Intern - 00810118340925

GFO74 Deaver, with Fiberoptic
Automated Medical Products Corp.
GFO74 Deaver, with Fiberoptic
In Commercial Distribution

  • 00810118340925 ()
GFO074

  • Surgical retractor/retraction system blade, reusable

Iron Intern - 00810118340918

GFO71 Harrington, with Fiber-optic
Automated Medical Products Corp.
GFO71 Harrington, with Fiberoptic
In Commercial Distribution

  • 00810118340918 ()
GFO071

  • Surgical retractor/retraction system blade, reusable

Orthopedical Surgical Instrument - 08059386742457

No Description
CITIEFFE SRL
T-handle with AO coupling
In Commercial Distribution

  • 08059386742457 ()
DT030970

  • Surgical instrument handle, non-torque-limiting

VESALIUS QUANTUM Galileo bipolar scissors - 08034055291559

No Description
TELEA ELECTRONIC ENGEENERING SRL
L=140mm with cable
In Commercial Distribution

  • 08034055291559 ()
2601018

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Fascile Continuous Peripheral Nerve Block Set - B372500003011

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
150mm, Kit with filter
In Commercial Distribution

  • B3723000303015 ()
  • B372500003011 ()

  • Length: 150 Millimeter
500003-01

  • Peripheral nerve-block sharp needle

Fascile Continuous Peripheral Nerve Block Set - B372500001011

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
70mm, Kit with filter
Not in Commercial Distribution

  • B3723000301015 ()
  • B372500001011 ()
  • B3721001385 ()

  • Length: 70 Millimeter
500001-01

  • Peripheral nerve-block sharp needle

Instrumentation Difra SA - B516311790

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516311790 ()
31179

  • Electronystagmograph
  • Dynamic visual acuity testing system

Instrumentation Difra - B516227090

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516227090 ()
22709

  • Electronystagmograph
  • Dynamic visual acuity testing system

Instrumentation Difra - B516222210

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516222210 ()
22221

  • Electronystagmograph
  • Dynamic visual acuity testing system

Study Kit - B14360200761

Single use study kit (compatible with thermistor).
Cleveland Medical Devices Inc.
Compatible with Thermistor - Single
In Commercial Distribution

  • B14360200761 ()
  • B14360200772 ()
  • B14360200782 ()
602-0076

  • Electroencephalograph

EXPERT - Flexible Joint Fixation System - 07899258663791

EXPERT ACL with augmentation - Flexible ACL Knotless Fixator with adjustable wire and tape for ligament augmentation
GM DOS REIS INDUSTRIA E COMERCIO LTDA
EXPERT ACL with augmentation
In Commercial Distribution

  • 07899258663791 ()
312-4000

  • Tendon/ligament bone anchor, non-bioabsorbable

TECO DIAGNOSTICS - 10673486000641

TECO DIAGNOSTICS URS-2K-100GL BOTTLE WITH LABEL
TECO DIAGNOSTICS
URS-2K-100GL BOTTLE WITH LABEL
In Commercial Distribution

  • 10673486000641 ()
URS-2K-100GL

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Redicare - B70901130700

Arterial Tourniquet with attached Windlass
REDICARE LLC
Arterial Tourniquet with Windlass
In Commercial Distribution

  • B70901130700 ()
0113070

  • Limb tourniquet, manual, single-use

Headrest - 07640132986600

No Description
Haag-Streit AG
With Lower Part Silver
In Commercial Distribution

  • 07640132986600 ()
1420186

  • Ophthalmic examination slit lamp

Headrest - 07640132986563

No Description
Haag-Streit AG
With Lower Part Silver
In Commercial Distribution

  • 07640132986563 ()
1420182

  • Ophthalmic examination slit lamp

RONDO' - 08056711928531

No Description
CITIEFFE SRL
Handle with AO coupling
In Commercial Distribution

  • 08056711928531 ()
VP-92011

  • Surgical instrument handle, non-torque-limiting

Reison - 07332339226893

I.V pole with clamp US size side rail
Stille AB
I.V pole with clamp
In Commercial Distribution

  • 07332339226893 ()
514-100401-US

  • Infusion/transfusion trolley

Reison - 07332339236779

Adjustable tray with clamp US size side rail
Stille AB
Adjustable tray with clamp
In Commercial Distribution

  • 07332339236779 ()
514-50-3SR037

  • Fluoroscopy/angiography table, powered

Piccolo Composite Nailing System - 07290117350683

Stopper Screw for use with the Piccolo Composite Proximal Femur Nailing System.
CARBOFIX ORTHOPEDICS LTD
Stopper Screw With Pin
In Commercial Distribution

  • 07290117350683 ()
PPF910550

  • Orthopaedic implant aiming arm

AcuPulse™ DUO HW Upgrade kit AcuPulse™ to DUO - 07290109142210

No Description
LUMENIS LTD.
Kit with prolonged arm
In Commercial Distribution

  • 07290109142210 ()


  • General/multiple surgical solid-state/carbon dioxide laser system

Connecting Tube - 06971162810728

No Description
Tianck Medical Co., Ltd.
25cm with three-way stopcock
In Commercial Distribution

  • 06971162810728 ()
044004

  • Invasive blood pressure monitoring tubing set

Connecting Tube - 06971162810711

No Description
Tianck Medical Co., Ltd.
20cm with three-way stopcock
In Commercial Distribution

  • 06971162810711 ()
044003

  • Invasive blood pressure monitoring tubing set

Connecting Tube - 06971162810704

No Description
Tianck Medical Co., Ltd.
15cm with three-way stopcock
In Commercial Distribution

  • 06971162810704 ()
044002

  • Invasive blood pressure monitoring tubing set

Yankauer Handle - 06971092637990

No Description
Shijiazhuang Yuanding Medical Device Co., LTD
Flat top with hole
In Commercial Distribution

  • 86971092637996 ()
  • 06971092637990 ()
YDSPH

  • Surgical/emergency suction cannula, non-illuminating, single-use

Yankauer Handle - 06971092637976

No Description
Shijiazhuang Yuanding Medical Device Co., LTD
Crown top with hole
In Commercial Distribution

  • 86971092637972 ()
  • 06971092637976 ()
YDSCH

  • Surgical/emergency suction cannula, non-illuminating, single-use

Connecting Tube - 06971162810698

No Description
Tianck Medical Co., Ltd.
10cm with three-way stopcock
In Commercial Distribution

  • 06971162810698 ()
044001

  • Invasive blood pressure monitoring tubing set

MedGyn Laminaria - M803021026

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 6 with buttons
In Commercial Distribution

  • M803021026 ()
021026

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021025

dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5 with button
In Commercial Distribution

  • M803021025 ()
021025

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021024

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 4 with buttons
In Commercial Distribution

  • M803021024 ()
021024

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021023

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 3 with button
In Commercial Distribution

  • M803021023 ()
021023

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021022

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 2 with button
In Commercial Distribution

  • M803021022 ()
021022

  • Hygroscopic cervical dilator

Natracare - 00782126009005

Organic Cotton Tampon, Menstrual, Unscented with Applicator Super 16 single use tampons per pack
BODYWISE (UK) LIMITED
Tampons with Applicator Super
In Commercial Distribution

  • 05019493090028 ()
  • 00782126009005 ()
  • 00782126009001 ()


  • Menstrual tampon, unscented

Natracare - 00782126008008

Organic Cotton Tampon, Menstrual, Unscented with Applicator Regular 16 single use tampons per pack
BODYWISE (UK) LIMITED
Tampons with Applicator Regular
In Commercial Distribution

  • 05019493080029 ()
  • 00782126008008 ()
  • 00782126008001 ()


  • Menstrual tampon, unscented

OsteoBridge™ IKA Knee Arthrodesis Nail - 04048266130969

TiAl6V4 ELI sterile
Merete GmbH
with Collar 18 200
In Commercial Distribution

  • 04048266130969 ()

  • Length: 200 Millimeter
  • Outer Diameter: 18 Millimeter
GA11820

  • Knee arthrodesis prosthesis

OsteoBridge™ IKA Knee Arthrodesis Nail - 04048266130945

TiAl6V4 ELI sterile
Merete GmbH
with Collar 14 200
In Commercial Distribution

  • 04048266130945 ()

  • Length: 200 Millimeter
  • Outer Diameter: 14 Millimeter
GA11420

  • Knee arthrodesis prosthesis

OsteoBridge™ IKA Knee Arthrodesis Nail - 04048266130938

TiAl6V4 ELI sterile
Merete GmbH
with Collar 16 200
In Commercial Distribution

  • 04048266130938 ()

  • Length: 200 Millimeter
  • Outer Diameter: 16 Millimeter
GA11620

  • Knee arthrodesis prosthesis

OsteoBridge™ IKA Knee Arthrodesis Nail - 04048266130921

TiAl6V4 ELI sterile
Merete GmbH
with Collar 18 150
In Commercial Distribution

  • 04048266130921 ()

  • Length: 150 Millimeter
  • Outer Diameter: 18 Millimeter
GA11815

  • Knee arthrodesis prosthesis

OsteoBridge™ IKA Knee Arthrodesis Nail - 04048266130914

TiAl6V4 ELI sterile
Merete GmbH
with Collar 18 130
In Commercial Distribution

  • 04048266130914 ()

  • Length: 130 Millimeter
  • Outer Diameter: 18 Millimeter
GA11813

  • Knee arthrodesis prosthesis
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