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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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Pachmate 2 Calbox - 00857377006339

The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
DGH TECHNOLOGY INC.
DGH 55B Calbox
In Commercial Distribution

  • 00857377006339 ()


  • Ultrasound pachymeter

2" round electrode - 00857771003286

ea
BIOMEDICAL LIFE SYSTEMS, INC.
EERD200M
In Commercial Distribution

  • 00857771003286 ()
EERD200M

  • Transcutaneous electrical stimulation electrode, single-use

AIMSCREEN MULTIDRUG 2 - 00695684402259

Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine 300 (COC 300) & Marijuana (THC).
GERMAINE LABORATORIES, INC
40225
In Commercial Distribution

  • 00695684402259 ()
  • 00695684402251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

Flexpress 2 Lite - 00714196792006

No Description
DERMARITE INDUSTRIES LLC
79200
In Commercial Distribution

  • 00714196792006 ()


  • Compression bandaging kit

mi-eye 2 160mm - 00861578000362

mi-eye 2 probe 160mm length for use with Trice Tablet 2
TRICE MEDICAL, INC.
T200-160
Not in Commercial Distribution

  • 00861578000362 ()

  • Length: 95 Millimeter


  • Rigid optical arthroscope, single-use

Trice Tablet 2 - 00861578000355

Tablet for use with mi-eye 2 probe. Reburbished.
TRICE MEDICAL, INC.
T200-001R
Not in Commercial Distribution

  • 00861578000355 ()


  • Endoscopic video image display unit

Trice Tablet 2 - 00861578000348

Tablet for use with mi-eye 2 probe
TRICE MEDICAL, INC.
T200-001
Not in Commercial Distribution

  • 00861578000348 ()


  • Endoscopic video image display unit

mi-eye 2 95mm - 00861578000331

mi-eye 2 probe 95mm length for use with Trice Tablet 2
TRICE MEDICAL, INC.
T200-095
Not in Commercial Distribution

  • 00861578000331 ()

  • Length: 95 Millimeter


  • Rigid optical arthroscope, single-use

Altair HI 2 - 00860013851521

Fiber Optic Headlight
QED, INC.
QED-7800
In Commercial Distribution

  • 00860013851521 ()


  • Head-worn fibreoptic light

Madsen Astera 2 - 05713315010194

1066 MADSEN Astera 2, W/O HDA, US Only
Natus Medical Denmark ApS
8-04-13403
In Commercial Distribution

  • 05713315010194 ()
8-04-13403

  • Speech audiometer
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