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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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Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
CRYOCONCEPTS, LP
1001-0375
In Commercial Distribution

  • 00850077006128 ()
  • 10850077006125 ()
60MC2 + 10

  • General cryosurgical system, cryogen gas, mechanical
CURETTE GRACEY, #9/10
BMT Medizintechnik GmbH
CU-9/10
In Commercial Distribution

  • 04251725205843 ()
CU-9/10

  • Bone curette, reusable
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.0911
In Commercial Distribution

  • EKAV100209110 ()
CL 10

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.001.5660
In Commercial Distribution

  • EKAV100156600 ()
10 LP

  • Dental surgical power tool motor, electric
A box of 10 CYP2C19 External Control Kits.
Spartan Bioscience Inc
01004880-ABC (10)
In Commercial Distribution

  • 00628055420095 ()
01004880-ABC (10)

  • Nucleic acid amplification mastermix kit IVD
" MRInnervu Prostate Endorectal Coil, Compatible with 1.0 Tesla for GE, Siemens, and Marconi. (PROSTATE PROBE (1.0),MC) (60727463)"
BAYER MEDICAL CARE INC.
BPX 10
In Commercial Distribution

  • 10616258009237 ()
  • 00616258009230 ()
BPX 10

  • MRI system coil, radio-frequency
AUTO I.D.® Plates - 10 x 6 Wells
IMMUNO CONCEPTS INC
7010 (10)
In Commercial Distribution

  • M7497010101 ()
7010 (10)

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion
nDNA 14 Well Slides - 10 Slides
IMMUNO CONCEPTS INC
3014 (10)
In Commercial Distribution

  • M7493014101 ()
3014 (10)

  • Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)
nDNA 7 Well Slides - 10 Slides
IMMUNO CONCEPTS INC
3007 (10)
In Commercial Distribution

  • M7493007101 ()
3007 (10)

  • Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)
ANA-Ro 14 Well HEp-2000® Slides - 10 Slides
IMMUNO CONCEPTS INC
2014-Ro (10)
In Commercial Distribution

  • M7492014RO101 ()
2014-Ro (10)

  • Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
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