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

  • 00813787021232 ()


  • Manual brachytherapy source, permanent implant
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 x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX782xi
In Commercial Distribution

  • 00813787021157 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iF
In Commercial Distribution

  • 00813787021133 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iN
In Commercial Distribution

  • 00813787021119 ()


  • Manual brachytherapy source, permanent implant
ConnectWeb viewer front-end with PACSCore back-end archive
Radius
3
In Commercial Distribution

  • B295FULLPACS30 ()


  • Radiological PACS software
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
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
No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge
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
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
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 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 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 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 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 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 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
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
F003.0018
In Commercial Distribution

  • B922F00300180 ()
F003.0018

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

  • 06944904003917 ()


  • Blood pressure cuff, reusable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12157
In Commercial Distribution

  • 06944904003900 ()


  • Blood pressure cuff, reusable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12161
In Commercial Distribution

  • 06944904003948 ()


  • Blood pressure cuff, reusable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12159
In Commercial Distribution

  • 06944904003924 ()


  • Blood pressure cuff, reusable
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
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
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
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
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
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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