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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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Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) - 00815568020922

Labelled with CE mark
KOBOLD, LLC
704-000
In Commercial Distribution

  • 00815568020922 ()


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Surgical Direct - B382SD12499A0

Cholangiogram Forceps with Ratchet
Surgical Direct, Inc.
SD12499A
In Commercial Distribution

  • B382SD12499A0 ()
SD12499A

  • Flexible endoscopic tissue manipulation forceps, single-use

Hip Instruments - 07630040735131

Large Blade with pins
Medacta International SA
01.15.10.0089
In Commercial Distribution

  • 07630040735131 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040735124

Small Blade with pins
Medacta International SA
01.15.10.0088
In Commercial Distribution

  • 07630040735124 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040753333

LBS with locking system
Medacta International SA
02.07.10.0104
In Commercial Distribution

  • 07630040753333 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

FibriJet - 00815634021730

Blending Connector with Mixer
Micromedics, Inc.
SA-3678
In Commercial Distribution

  • 10815634021737 ()
  • 00815634021730 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Heated Eye Pad Pro - B172PRO0

Ophthalmic warmer with timer
DIGITAL HEAT CORPORATION
Heated Eye Pad Pro
In Commercial Distribution

  • B172PRO0 ()


  • Eye heat therapy pack, reusable

MicroFrance® - 10381780099451

Monopolar Forceps with Teeth
INTEGRA MICROFRANCE
CP390-8
In Commercial Distribution

  • 10381780099451 ()

  • Length: 190 Millimeter
CP390-8

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Nuwave - 00812970012026

NUWAVE with Large Bag
EXCELERON MEDICAL, INC.
NW-003
In Commercial Distribution

  • 00812970012026 ()
NW-003

  • Home CPAP/BPAP washer-disinfector (ozone)

Nuwave - 00812970012019

NUWAVE with Small Bag
EXCELERON MEDICAL, INC.
NW-002
In Commercial Distribution

  • 00812970012019 ()
NW-002

  • Home CPAP/BPAP washer-disinfector (ozone)
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