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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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Boomerang with Velcro - B525FI01A0

No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge

VORTRAN-IPPB with Manomter - 10637320040224

The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
VORTRAN MEDICAL TECHNOLOGY 1, INC
IPM-4022
In Commercial Distribution

  • 20637320040221 ()
  • 10637320040224 ()
IPM-4022

  • Ultrasonic nebulizing system

ASPIJECT WITH O-RING - 00303620000017

Dental cartridge syringe
SEPTODONT, INC
01N2030
In Commercial Distribution

  • 00303620000017 ()

  • Total Volume: 1.8 Milliliter
01N2030

  • Syringe-loaded medication/vaccine injector, manual, professional

Awl With Stop - B806RO0016ASZZ0

Awl With Stop
Spineup, Inc.
RO0016ASZZ
In Commercial Distribution

  • B806RO0016ASZZ0 ()
RO0016ASZZ

  • Bone awl, reusable

MRIaudioPREM1001 with MRIview - B66935011

The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3501
In Commercial Distribution

  • B66935011 ()
3501

  • Patient audiovisual communication/entertainment system

MRIaudioPREM1000 with MRIview - B66935001

The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3500
In Commercial Distribution

  • B66935001 ()
3500

  • Patient audiovisual communication/entertainment system

Celebrate with Reese's - 00017276238822

Adhesive Bandages, scary designs, 3/4 IN x 3 IN (19 mm x 76 mm)
Aso LLC
017276238822
In Commercial Distribution

  • 60017276238824 ()
  • 00017276238822 ()


  • Skin-cover adhesive strip, non-antimicrobial

SSU-D with Orifice - 00896241002510

The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002517 ()
  • 00896241002510 ()
  • 20896241002514 ()


  • Microbial water purification filter, non-sterilizable

SSU-D with Orifice - 00896241002503

The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002500 ()
  • 00896241002503 ()


  • Microbial water purification filter, non-sterilizable

Hayrake-Palatal with Spurs - 00889989083545

Hayrake-Palatal with Spurs
ALLESEE AOA-PRO
3000-0073
In Commercial Distribution

  • 00889989083545 ()


  • Orthodontic habit prevention/breaking appliance, bonded

SPECTRUM WITH MDL - 00085412091570

The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling.
BAXTER INTERNATIONAL INC.
35700BAX
In Commercial Distribution

  • 00085412091570 ()
35700BAX

  • Bedside infusion pump, single-channel

Tray With Brackets - 00192896121072

Tray With Brackets Stainless Steel
SONTEC INSTRUMENTS, INC.
18-2001
In Commercial Distribution

  • 00192896121072 ()

  • Height: 14 Millimeter
  • Length: 400 Millimeter
  • Width: 250 Millimeter
18-2001

  • Instrument tray, reusable

Probe With Eye - 00192896116252

Probe With Eye Stainless
SONTEC INSTRUMENTS, INC.
197-662
In Commercial Distribution

  • 00192896116252 ()

  • Length: 5.5 Inch
197-662

  • Gastro-urological director

Probe With Eye - 00192896110076

Probe With Eye Stainless Steel
SONTEC INSTRUMENTS, INC.
197-666
In Commercial Distribution

  • 00192896110076 ()

  • Length: 9 Inch


  • Gastro-urological director

Osteotome With Guide - 00192896108929

Osteotome With Guide Straight 3 Millimeters
SONTEC INSTRUMENTS, INC.
475-785G2
In Commercial Distribution

  • 00192896108929 ()

  • Length: 7.25 Inch


  • Plastic surgery osteotome

Drill with stop - 04048844402334

No Description
implantcast GmbH
42240135
In Commercial Distribution

  • 04048844402334 ()

  • 2.5mm


  • Medullary canal orthopaedic reamer, rigid

INSERT WITH MAT - 00192896019430

INSERT WITH MAT
SONTEC INSTRUMENTS, INC.
1103-7171
In Commercial Distribution

  • 00192896019430 ()

  • Length: 11 Inch
  • Height: 1.5 Inch
  • Width: 7 Inch
1103-7171

  • Instrument tray, reusable

Trolley with pylon - 06972197480900

No Description
Hunan Vathin Medical Instrument Co., Ltd
MET-A2
In Commercial Distribution

  • 06972197480900 ()


  • Examination/operating table component trolley

Perfadex with THAM - 07350069520067

Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size 2 x 2800 ml
Xvivo Perfusion AB
19018
Not in Commercial Distribution

  • 07350069520067 ()
19018

  • Donor-organ/tissue/cell preservation solution

Perfadex with THAM - 07350069520050

Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 8x 1000 ml
Xvivo Perfusion AB
19017
Not in Commercial Distribution

  • 07350069520050 ()
19017

  • Donor-organ/tissue/cell preservation solution

MaxBraid with RigidStitch - 00810020088311

Suture
RIVERPOINT MEDICAL, LLC
110045781
In Commercial Distribution

  • 00810020088311 ()


  • Polyolefin/fluoropolymer suture, multifilament

MaxBraid with RigidStitch - 00810020088304

Suture
RIVERPOINT MEDICAL, LLC
110045780
In Commercial Distribution

  • 00810020088304 ()


  • Polyolefin/fluoropolymer suture, multifilament

MaxBraid with RigidStitch - 00810020088298

Suture Tape
RIVERPOINT MEDICAL, LLC
110045779
In Commercial Distribution

  • 00810020088298 ()


  • Polyolefin/fluoropolymer suture, multifilament

MaxBraid with RigidStitch - 00810020088281

Suture Tape
RIVERPOINT MEDICAL, LLC
110045778
In Commercial Distribution

  • 00810020088281 ()


  • Polyolefin/fluoropolymer suture, multifilament

MaxBraid with RigidStitch - 00810020088274

Suture
RIVERPOINT MEDICAL, LLC
110045777
In Commercial Distribution

  • 00810020088274 ()


  • Polyolefin/fluoropolymer suture, multifilament

MaxBraid with RigidStitch - 00810020088267

Suture
RIVERPOINT MEDICAL, LLC
110045776
In Commercial Distribution

  • 00810020088267 ()


  • Polyolefin/fluoropolymer suture, multifilament

Cuff with connector - 06944904003948

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12161
In Commercial Distribution

  • 06944904003948 ()


  • Blood pressure cuff, reusable

Cuff with connector - 06944904003924

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12159
In Commercial Distribution

  • 06944904003924 ()


  • Blood pressure cuff, reusable

Cuff with connector - 06944904003917

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12158
In Commercial Distribution

  • 06944904003917 ()


  • Blood pressure cuff, reusable

Cuff with connector - 06944904003900

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12157
In Commercial Distribution

  • 06944904003900 ()


  • Blood pressure cuff, reusable

Affinity with accessories - 07290017249001

Affinity is a device used to clean a tissue (skin) by tiny jets of sterile fluid
TAVGER LTD
FG00004
In Commercial Distribution

  • 07290017249001 ()


  • Surgical/orthopaedic lavage control unit

Syringe with needle - 06958697602875

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602872 ()
  • 06958697602875 ()
  • 26958697602879 ()
T1ML2325E

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602813

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 25G X 1"
In Commercial Distribution

  • 16958697602810 ()
  • 06958697602813 ()
  • 26958697602817 ()
SLL3N2525

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602554

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 25G X 1 1/2"
In Commercial Distribution

  • 16958697602551 ()
  • 06958697602554 ()
  • 26958697602558 ()
SLS1N2538

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602530

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 25G X 1"
In Commercial Distribution

  • 16958697602537 ()
  • 06958697602530 ()
  • 26958697602534 ()
SLS1N2525

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602523

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 23G X 1"
In Commercial Distribution

  • 16958697602520 ()
  • 06958697602523 ()
  • 26958697602527 ()
T3ML2325E

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602424

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602421 ()
  • 06958697602424 ()
  • 26958697602428 ()
SLS1N2325

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602806

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 23G X 1"
In Commercial Distribution

  • 16958697602803 ()
  • 06958697602806 ()
  • 26958697602800 ()
SLL3N2325

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602790

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602797 ()
  • 06958697602790 ()
  • 26958697602794 ()
SLL1N2325

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602752

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602759 ()
  • 06958697602752 ()
  • 26958697602756 ()
T1ML2325E

  • Metered-delivery hypodermic syringe
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