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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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AnchorSeed with I-Seed - 00813787021324

AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77315iN
In Commercial Distribution

  • 00813787021324 ()


  • Manual brachytherapy source, permanent implant

VariStrand with OncoSeed - 00813787021232

VariStrand with OncoSeed, x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
ON772xi
In Commercial Distribution

  • 00813787021232 ()


  • Manual brachytherapy source, permanent implant

VariStrand with I-Seed - 00813787021171

VariStrand with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX772xi
In Commercial Distribution

  • 00813787021171 ()


  • Manual brachytherapy source, permanent implant

AnchorLoad with I-Seed - 00813787021157

AnchorLoad with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX782xi
In Commercial Distribution

  • 00813787021157 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with I-Seed - 00813787021133

AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iF
In Commercial Distribution

  • 00813787021133 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with I-Seed - 00813787021119

AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iN
In Commercial Distribution

  • 00813787021119 ()


  • Manual brachytherapy source, permanent implant

ConnectWeb with PACSCore - B295FULLPACS30

ConnectWeb viewer front-end with PACSCore back-end archive
Radius
3
In Commercial Distribution

  • B295FULLPACS30 ()


  • Radiological PACS software

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

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

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

FluoroMounter with DAPI - B502BSB01680

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB01680 ()
BSB 0168

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01670

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
500 ml
In Commercial Distribution

  • B502BSB01670 ()
BSB 0167

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01660

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB01660 ()
BSB 0166

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01650

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB01650 ()
BSB 0165

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01640

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB01640 ()
BSB 0164

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01630

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB01630 ()
BSB 0163

  • DAPI solution IVD

Driver with Sleeve - B922F00300180

Driver with Sleeve
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
F003.0018
In Commercial Distribution

  • B922F00300180 ()
F003.0018

  • Surgical screwdriver, 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

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

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 - 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 - 06958697602745

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

  • 16958697602742 ()
  • 06958697602745 ()
  • 26958697602749 ()
T3ML2325E

  • 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
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