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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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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

Hayrake-Palatal with Spurs - 00889989083545

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

  • 00889989083545 ()


  • Orthodontic habit prevention/breaking appliance, bonded

Boomerang with Velcro - B525FI01A0

No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge

BG545 with EPI28A - B101100743XI0

No Description
CME AMERICA LLC
100-743XI
Not in Commercial Distribution

  • B101100743XI0 ()


  • Bedside infusion pump, single-channel

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

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

EBA WITH SOCKETS-22WIRES - 00811478011739

No Description
ELECTRO-CAP INTERNATIONAL INC
E2S-22WIRE
In Commercial Distribution

  • 00811478011739 ()
E2S-22WIRE

  • Analytical scalp lead

EBA WITH SOCKETS - 00811478011593

No Description
ELECTRO-CAP INTERNATIONAL INC
E2S
In Commercial Distribution

  • 00811478011593 ()
E2S

  • Analytical scalp lead

ConnectWeb with PACSCore - B295FULLPACS30

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

  • B295FULLPACS30 ()


  • Radiological PACS software

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

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
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