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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TheraSleeve with x = 1-12 seeds and 0 or more markers
THERAGENICS CORPORATION
XX992x
In Commercial Distribution

  • 00813787020907 ()


  • Manual brachytherapy source, permanent implant
TheraSleeve with x = 1-20 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX92x
In Commercial Distribution

  • 00813787020884 ()


  • Manual brachytherapy source, permanent implant
TheraLoad® with x = 1-20 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX82x
In Commercial Distribution

  • 00813787020860 ()


  • Manual brachytherapy source, permanent implant
TheraStrand with 10 seeds and 0 or spacers in Mesh
THERAGENICS CORPORATION
XX7210SM
In Commercial Distribution

  • 00813787020853 ()


  • Manual brachytherapy source, permanent implant
TheraStrand with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX72x
In Commercial Distribution

  • 00813787020846 ()


  • Manual brachytherapy source, permanent implant
Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind.
THERAGENICS CORPORATION
XX72xLN
In Commercial Distribution

  • 00813787020839 ()


  • Manual brachytherapy source, permanent implant
Loose TheraStrand with 1-6 seeds, standard spacing
THERAGENICS CORPORATION
XX72xL
In Commercial Distribution

  • 00813787020822 ()


  • Manual brachytherapy source, permanent implant
TheraStrand TSL in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215F
In Commercial Distribution

  • 00813787020792 ()


  • Manual brachytherapy source, permanent implant
TheraStrand TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215N
In Commercial Distribution

  • 00813787020785 ()


  • Manual brachytherapy source, permanent implant
TheraStrand TSL in TPSII Single – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215
In Commercial Distribution

  • 00813787020778 ()


  • Manual brachytherapy source, permanent implant
Tamper Evident Cap for Use With ENFit® Syringes (ETEC)
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-220-100
In Commercial Distribution

  • B21257220100 ()
  • B212572201001 ()
  • B212572201000 ()
57-220-100

  • ENFit-formatted protective cap
Disposable patient interface with filter 0004-4012
Shape Medical Systems, Inc.
0004-4012
In Commercial Distribution

  • B20044012 ()


  • Pulmonary function testing kit
12-(12ml) Sperm Wash Modified HTF Medium w/Gentamicin
VITROLIFE INC.
15262
In Commercial Distribution

  • 10805360016855 ()
  • 00805360016858 ()

  • Total Volume: 12 Milliliter


  • Spermatozoa/semen motility medium supplement
No Description
Aktina Corp.
60-311
In Commercial Distribution

  • B365603110 ()


  • Radiological compression belt
PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive
Radius
7
In Commercial Distribution

  • B295VNA70 ()


  • Radiological PACS software
Modified Ham's F-10 w/Albumin
FUJIFILM IRVINE SCIENTIFIC, INC.
99109-100ML
Not in Commercial Distribution

  • 00893727002941 ()

  • Total Volume: 100 Milliliter
99109

  • IVF medium
Modified Ham's F-10 w/Albumin
FUJIFILM IRVINE SCIENTIFIC, INC.
99109-12X12ML
Not in Commercial Distribution

  • 00893727002934 ()
  • 10893727002931 ()

  • Total Volume: 12 Milliliter
99109

  • IVF medium
Modified HTF Medium-HEPES
FUJIFILM IRVINE SCIENTIFIC, INC.
90126-500mL
In Commercial Distribution

  • 00893727002927 ()

  • Total Volume: 500 Milliliter
90126

  • IVF medium
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-100ML
In Commercial Distribution

  • 00893727002408 ()

  • Total Volume: 100 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-100ML
In Commercial Distribution

  • 00893727002392 ()

  • Total Volume: 100 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
P-1 Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
99242-100mL
In Commercial Distribution

  • 00893727002347 ()

  • Total Volume: 100 Milliliter
99242

  • IVF medium
Complete MultiBlast With DSS
FUJIFILM IRVINE SCIENTIFIC, INC.
90143-2X20mL
Not in Commercial Distribution

  • 00893727002293 ()
  • 10893727002290 ()

  • Total Volume: 20 Milliliter
90143

  • IVF medium
Modified HTF Medium-HEPES
FUJIFILM IRVINE SCIENTIFIC, INC.
90126-100mL
In Commercial Distribution

  • 00893727002194 ()

  • Total Volume: 100 Milliliter
90126

  • IVF medium
Polyvinylpyrrolidone (PVP) Solution with HSA - 10%
FUJIFILM IRVINE SCIENTIFIC, INC.
90123-5X0.5mL
In Commercial Distribution

  • 00893727002170 ()
  • 18937270021703 ()

  • Total Volume: 0.5 Milliliter
90123

  • Assisted reproduction microtool
Polyvinylpyrrolidone (PVP) Solution with HSA - 7%
FUJIFILM IRVINE SCIENTIFIC, INC.
90121-5X0.5mL
In Commercial Distribution

  • 00893727002163 ()
  • 18937270021635 ()

  • Total Volume: 0.5 Milliliter
90121

  • Assisted reproduction microtool
L Hook non-stick with cable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLHOOK445C
Not in Commercial Distribution

  • B354OSLHOOK445C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Acetabular Cup with Ti-Coat, size 64mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.64.000
In Commercial Distribution

  • 00814703017476 ()

  • size 64mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 62mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.62.000
In Commercial Distribution

  • 00814703017469 ()

  • size 62mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 60mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.60.000
In Commercial Distribution

  • 00814703017452 ()

  • size 60mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 58mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.58.000
In Commercial Distribution

  • 00814703017445 ()

  • size 58mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 56mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.56.000
In Commercial Distribution

  • 00814703017438 ()

  • size 56mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 54mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.54.000
In Commercial Distribution

  • 00814703017421 ()

  • size 54mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 52mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.52.000
In Commercial Distribution

  • 00814703017414 ()

  • size 52mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 50mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.50.000
In Commercial Distribution

  • 00814703017407 ()

  • size 50mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 48mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.48.000
In Commercial Distribution

  • 00814703017391 ()

  • size 48mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 46mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.46.000
In Commercial Distribution

  • 00814703017384 ()

  • size 46mm


  • Metallic acetabulum prosthesis
Acetabular Cup with Ti-Coat, size 44mm
TOTAL JOINT ORTHOPEDICS, INC.
3401.44.000
In Commercial Distribution

  • 00814703017377 ()

  • size 44mm


  • Metallic acetabulum prosthesis
Femur with Cobalt 3D, size 7
TOTAL JOINT ORTHOPEDICS, INC.
5106.07.000
In Commercial Distribution

  • 00814703016769 ()

  • size 7


  • Coated knee femur prosthesis
Femur with Cobalt 3D, size 6
TOTAL JOINT ORTHOPEDICS, INC.
5106.06.000
In Commercial Distribution

  • 00814703016752 ()

  • size 6


  • Coated knee femur prosthesis
Femur with Cobalt 3D, size 5
TOTAL JOINT ORTHOPEDICS, INC.
5106.05.000
In Commercial Distribution

  • 00814703016745 ()

  • size 5


  • Coated knee femur prosthesis
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