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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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Imperial Stainless Steel Basin - 07540162040283

7 Qt Stainless Steel Basin for OR-36510 and OR-36520
Imperial Surgical Ltd
OR-36510-BS
In Commercial Distribution

  • 07540162040283 ()
OR-36510-BS

  • Bowl/basin stand

Imperial Oval Stainless Steel Basin - 07540162040276

10 Qt Oval Stainless Steel Basin for OR-3632
Imperial Surgical Ltd
OR-3632-BS
In Commercial Distribution

  • 07540162040276 ()
OR-3632-BS

  • Bowl/basin stand

Imperial Stainless Steel Pail - 07540162040269

12 Qt Stainless Steel Pail for OR-3631, OR-36310 and OR-3631-TB
Imperial Surgical Ltd
OR-3631-PS
In Commercial Distribution

  • 07540162040269 ()
OR-3631-PS

  • Bowl/basin stand

Millennium - 00190776379094

Small basin with handle, 8-10 oz
Avalign Technologies, Inc.
1-117380C
In Commercial Distribution

  • 00190776379094 ()


  • Bowl/basin stand

One Degree Medical - 00860003583067

Fluid Warming System Stand - ODM-STN01
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-STN01
In Commercial Distribution

  • 00860003583067 ()


  • Bowl/basin stand

Stool Bacterial Pathogens Panel - B178GBSBPP100

Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

E 3-12 - 08056304453891

No Description
ESAOTE SPA
120000038
In Commercial Distribution

  • 08056304453891 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

E+R - 06975871430376

DOUBLE HEAD STETHOSCOPE PINK
Wenzhou Caretek Medical Device Co., Ltd.
143212
In Commercial Distribution

  • 06975871430376 ()


  • Mechanical external stethoscope

E+R - 06975871430369

DOUBLE HEAD STETHOSCOPE PURPLE
Wenzhou Caretek Medical Device Co., Ltd.
143231
In Commercial Distribution

  • 06975871430369 ()


  • Mechanical external stethoscope

E+R - 06975871430352

DOUBLE HEAD STETHOSCOPE YELLOW
Wenzhou Caretek Medical Device Co., Ltd.
143226
In Commercial Distribution

  • 06975871430352 ()


  • Mechanical external stethoscope

T-MAT E - 40889978450943

T-MAT E 50SH 18x24cm film
CARESTREAM HEALTH, INC.
T-MAT E
In Commercial Distribution

  • 60889978450947 ()
  • 40889978450943 ()
  • 00889978450945 ()
8450942

  • Dental x-ray film, screen

T-MAT E - 40889975216771

T-MAT E 100SH 12.7x30.5cm film
CARESTREAM HEALTH, INC.
T-MAT E
In Commercial Distribution

  • 60889975216775 ()
  • 40889975216771 ()
  • 00889975216773 ()
5216775

  • Dental x-ray film, screen

T-MAT E - 40889975216740

T-MAT E 100SH 15x30cm film
CARESTREAM HEALTH, INC.
T-MAT E
In Commercial Distribution

  • 60889975216744 ()
  • 40889975216740 ()
  • 00889975216742 ()
5216742

  • Dental x-ray film, screen

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

E- Handle - 10812269022658

E-Handle, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000606AO
In Commercial Distribution

  • 10812269022658 ()
MDS000606AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

AMC&E - 10817357021247

AMC&E 5-Lead Grouped Set, Pinch (Grabber) to Multi-Link® Shielded Disposable, 50in.
HYGIA HEALTH SERVICES, INC.
LW-341DS50/5A
Not in Commercial Distribution

  • 30817357021241 ()
  • 10817357021247 ()


  • Electrocardiographic lead set, reprocessed

AMC&E - 10817357020837

AMC&E 5-lead DIN to Pinch Telemetry Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/5AT
Not in Commercial Distribution

  • 30817357020831 ()
  • 10817357020837 ()


  • Electrocardiographic lead set, reprocessed

AMC&E - 10817357020578

AMC&E 3-lead DIN to Pinch Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/3A
Not in Commercial Distribution

  • 30817357020572 ()
  • 10817357020578 ()


  • Electrocardiographic lead set, reprocessed

AMC&E - 10817357020486

AMC&E 5-lead DIN to Pinch Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/5A
Not in Commercial Distribution

  • 30817357020480 ()
  • 10817357020486 ()


  • Electrocardiographic lead set, reprocessed

E SERIES - 00847946019587

Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS w/GPS, PACE, DC, LI-ION, NO RAILS, DMST, REFURB
Zoll Medical Corporation
80011740030124012
In Commercial Distribution

  • 00847946019587 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
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