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

  • 07640132986600 ()
1420186

  • Ophthalmic examination slit lamp
No Description
Haag-Streit AG
With Lower Part Silver
In Commercial Distribution

  • 07640132986563 ()
1420182

  • Ophthalmic examination slit lamp
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
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
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
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
ALLWIN MEDICAL DEVICES, INC.
6F, 26cm with Suture
In Commercial Distribution

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

  • Polymeric ureteral stent
7F, 24cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 24cm with Suture
In Commercial Distribution

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

  • Polymeric ureteral stent
7F, 22cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 22cm with Suture
In Commercial Distribution

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

  • Polymeric ureteral stent
No Description
LUMENIS LTD.
Kit with prolonged arm
In Commercial Distribution

  • 07290109142210 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 6 with buttons
In Commercial Distribution

  • M803021026 ()
021026

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

  • M803021025 ()
021025

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

  • M803021024 ()
021024

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

  • M803021023 ()
021023

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

  • M803021022 ()
021022

  • Hygroscopic cervical dilator
Siemens UNITY 3 WITH INSERTS
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERTS
Not in Commercial Distribution

  • 57117810000743 ()
10824331

  • Audiometric/hearing aid tester
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
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
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
GFO74 Deaver, with Fiberoptic
Automated Medical Products Corp.
GFO74 Deaver, with Fiberoptic
In Commercial Distribution

  • 00810118340925 ()
GFO074

  • Surgical retractor/retraction system blade, reusable
GFO71 Harrington, with Fiber-optic
Automated Medical Products Corp.
GFO71 Harrington, with Fiberoptic
In Commercial Distribution

  • 00810118340918 ()
GFO071

  • Surgical retractor/retraction system blade, reusable
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
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
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
No Description
Tianck Medical Co., Ltd.
25cm with three-way stopcock
In Commercial Distribution

  • 06971162810728 ()
044004

  • Invasive blood pressure monitoring tubing set
No Description
Tianck Medical Co., Ltd.
20cm with three-way stopcock
In Commercial Distribution

  • 06971162810711 ()
044003

  • Invasive blood pressure monitoring tubing set
No Description
Tianck Medical Co., Ltd.
15cm with three-way stopcock
In Commercial Distribution

  • 06971162810704 ()
044002

  • Invasive blood pressure monitoring tubing set
No Description
Tianck Medical Co., Ltd.
10cm with three-way stopcock
In Commercial Distribution

  • 06971162810698 ()
044001

  • Invasive blood pressure monitoring tubing set
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
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
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
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
TiAl6V4 ELI sterile
Merete GmbH
with Collar 18 200
In Commercial Distribution

  • 04048266130969 ()

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

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 14 200
In Commercial Distribution

  • 04048266130945 ()

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

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 16 200
In Commercial Distribution

  • 04048266130938 ()

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

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 18 150
In Commercial Distribution

  • 04048266130921 ()

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

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 18 130
In Commercial Distribution

  • 04048266130914 ()

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

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 12 200
In Commercial Distribution

  • 04048266130907 ()

  • Length: 200 Millimeter
  • Outer Diameter: 12 Millimeter
GA11220

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 16 150
In Commercial Distribution

  • 04048266078889 ()

  • Length: 150 Millimeter
  • Outer Diameter: 16 Millimeter
GA11615

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 16 130
In Commercial Distribution

  • 04048266078872 ()

  • Length: 130 Millimeter
  • Outer Diameter: 16 Millimeter
GA11613

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 14 150
In Commercial Distribution

  • 04048266078858 ()

  • Length: 150 Millimeter
  • Outer Diameter: 14 Millimeter
GA11415

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 14 130
In Commercial Distribution

  • 04048266078841 ()

  • Length: 130 Millimeter
  • Outer Diameter: 14 Millimeter
GA11413

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 12 150
In Commercial Distribution

  • 04048266078827 ()

  • Length: 150 Millimeter
  • Outer Diameter: 12 Millimeter
GA11215

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 12 130
In Commercial Distribution

  • 04048266078810 ()

  • Length: 130 Millimeter
  • Outer Diameter: 12 Millimeter
GA11213

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 10 150
In Commercial Distribution

  • 04048266078797 ()

  • Length: 150 Millimeter
  • Outer Diameter: 10 Millimeter
GA11015

  • Knee arthrodesis prosthesis
TiAl6V4 ELI sterile
Merete GmbH
with Collar 10 130
In Commercial Distribution

  • 04048266078780 ()

  • Length: 130 Millimeter
  • Outer Diameter: 10 Millimeter
GA11013

  • Knee arthrodesis prosthesis
Cage Inserter(with Stopper)
Zsfab, Inc.
Cage Inserter(with Stopper)
In Commercial Distribution

  • 00810136250800 ()


  • Metallic spinal interbody fusion cage
No Description
Biomet Orthopedics, LLC
161088
In Commercial Distribution

  • 00880304554689 ()

  • Standard 63 mm With Plug
161088

  • Coated knee tibia prosthesis
No Description
Biomet Orthopedics, LLC
414848
In Commercial Distribution

  • 00880304369986 ()

  • 6MM X 150MM / WITH FLANGE
414848

  • Elbow ulna prosthesis trial
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