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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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therascreen® FGFR RGQ RT-PCR Kit - 04053228043560

The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228043560 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)

QuickGraft - W41844300PSTT165

QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft

MEDLINE - 10080196652532

BLADE GLOVE NUMBER 11 S.S.
MEDLINE INDUSTRIES, INC.
MDS15411
In Commercial Distribution

  • 40080196652533 ()
  • 10080196652532 ()
MDS15411

  • Scalpel handle, single-use

MEDLINE - 10080196652518

BLADE GLOVE NUMBER 10 S.S.
MEDLINE INDUSTRIES, INC.
MDS15410
In Commercial Distribution

  • 40080196652519 ()
  • 10080196652518 ()
MDS15410

  • Scalpel handle, single-use

maguja - 06934832600630

Infrared Thermometer Model Number RN-60A
Ningbo Ranor Medical Science & Technology Co., Ltd
RN-60B
In Commercial Distribution

  • 06934832600630 ()


  • Infrared patient thermometer, skin

maguja - 06934832600623

Infrared Thermometer Model Number RN-60A
Ningbo Ranor Medical Science & Technology Co., Ltd
RN-60A
In Commercial Distribution

  • 06934832600623 ()


  • Infrared patient thermometer, skin

maguja - 06934832600586

Infrared Thermometer Model Number RN-50B
Ningbo Ranor Medical Science & Technology Co., Ltd
RN-50B
In Commercial Distribution

  • 06934832600586 ()


  • Infrared patient thermometer, skin

maguja - 06934832600517

Infrared Thermometer Model Number RN-50A
Ningbo Ranor Medical Science & Technology Co., Ltd
RN-50A
In Commercial Distribution

  • 06934832600517 ()


  • Infrared patient thermometer, skin

CLARITY II - 08809447652610

COMPL_BODY_AIR Package DI Number : 08809447652634
Lutronic Corporation
COMPL_BODY_AIR
In Commercial Distribution

  • 08809447652610 ()


  • Dermatological solid-state laser system

CLARITY II - 08809447652559

COMPL_POLE_FIBER Package DI Number:08809447652627
Lutronic Corporation
COMPL_POLE_FIBER
In Commercial Distribution

  • 08809447652559 ()


  • Dermatological solid-state laser system

LOSPA IS Spinal System - 08806373812910

Set screw Wrong DI Number
Corentec Co., Ltd
00.00.0000
In Commercial Distribution

  • 08806373812910 ()


  • Bone-screw internal spinal fixation system, non-sterile

Darby Dental Supply, LLC - 00889813033159

POLY CROWNS REFILL Number 303
DARBY DENTAL SUPPLY, LLC
9518583
In Commercial Distribution

  • 00889813033142 ()
  • 00889813033159 ()
9518583

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033135

POLY CROWNS REFILL Number 302
DARBY DENTAL SUPPLY, LLC
9518582
In Commercial Distribution

  • 00889813033128 ()
  • 00889813033135 ()
9518582

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033111

POLY CROWNS REFILL Number 301
DARBY DENTAL SUPPLY, LLC
9518581
In Commercial Distribution

  • 00889813033104 ()
  • 00889813033111 ()
9518581

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033098

POLY CROWNS REFILL Number 300
DARBY DENTAL SUPPLY, LLC
9518580
In Commercial Distribution

  • 00889813033081 ()
  • 00889813033098 ()
9518580

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033074

POLY CROWNS REFILL Number 200
DARBY DENTAL SUPPLY, LLC
9518579
In Commercial Distribution

  • 00889813033067 ()
  • 00889813033074 ()
9518579

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033050

POLY CROWNS REFILL Number 103
DARBY DENTAL SUPPLY, LLC
9518578
In Commercial Distribution

  • 00889813033043 ()
  • 00889813033050 ()
9518578

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033036

POLY CROWNS REFILL Number 102
DARBY DENTAL SUPPLY, LLC
9518577
In Commercial Distribution

  • 00889813033029 ()
  • 00889813033036 ()
9518577

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813033012

POLY CROWNS REFILL Number 101
DARBY DENTAL SUPPLY, LLC
9518576
In Commercial Distribution

  • 00889813033005 ()
  • 00889813033012 ()
9518576

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032992

POLY CROWNS REFILL Number 100
DARBY DENTAL SUPPLY, LLC
9518575
In Commercial Distribution

  • 00889813032985 ()
  • 00889813032992 ()
9518575

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032978

POLY CROWNS REFILL Number 69
DARBY DENTAL SUPPLY, LLC
9518574
In Commercial Distribution

  • 00889813032961 ()
  • 00889813032978 ()
9518574

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032954

POLY CROWNS REFILL Number 68
DARBY DENTAL SUPPLY, LLC
9518573
In Commercial Distribution

  • 00889813032947 ()
  • 00889813032954 ()
9518573

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032930

POLY CROWNS REFILL Number 67
DARBY DENTAL SUPPLY, LLC
9518572
In Commercial Distribution

  • 00889813032923 ()
  • 00889813032930 ()
9518572

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032916

POLY CROWNS REFILL Number 66
DARBY DENTAL SUPPLY, LLC
9518571
In Commercial Distribution

  • 00889813032909 ()
  • 00889813032916 ()
9518571

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032893

POLY CROWNS REFILL Number 65
DARBY DENTAL SUPPLY, LLC
9518570
In Commercial Distribution

  • 00889813032886 ()
  • 00889813032893 ()
9518570

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032879

POLY CROWNS REFILL Number 64
DARBY DENTAL SUPPLY, LLC
9518569
In Commercial Distribution

  • 00889813032862 ()
  • 00889813032879 ()
9518569

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032855

POLY CROWNS REFILL Number 63
DARBY DENTAL SUPPLY, LLC
9518568
In Commercial Distribution

  • 00889813032848 ()
  • 00889813032855 ()
9518568

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032831

POLY CROWNS REFILL Number 62
DARBY DENTAL SUPPLY, LLC
9518567
In Commercial Distribution

  • 00889813032824 ()
  • 00889813032831 ()
9518567

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032817

POLY CROWNS REFILL Number 61
DARBY DENTAL SUPPLY, LLC
9518566
In Commercial Distribution

  • 00889813032800 ()
  • 00889813032817 ()
9518566

  • Preformed dental crown, temporary

Darby Dental Supply, LLC - 00889813032794

POLY CROWNS REFILL Number 60
DARBY DENTAL SUPPLY, LLC
9518565
In Commercial Distribution

  • 00889813032787 ()
  • 00889813032794 ()
9518565

  • Preformed dental crown, temporary
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