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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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RESPONDER 5, ENHANCED, GETWELL - 00840828156219

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C410U-701033F
In Commercial Distribution

  • 00840828156219 ()
21385

  • Pillow speaker

MALU Axle, Pk/5 - 00889989083286

MALU Axle, Pk/5
ALLESEE AOA-PRO
MATER21
In Commercial Distribution

  • 10889989083283 ()
  • 00889989083286 ()


  • Orthodontic clasp, metal, custom-made

AdvanSync Extender, Pk/5 - 00889989083194

AdvanSync Extender, Pk/5
ALLESEE AOA-PRO
MATER201
In Commercial Distribution

  • 10889989083191 ()
  • 00889989083194 ()


  • Orthodontic clasp, metal, custom-made

CYSTATHIONINE PLUS LEVEL 5 - B800CYST5LC0

CYSTATHIONINE PLUS LEVEL 5
UTAK LABORATORIES, INC.
CYST+ 5 LC
In Commercial Distribution

  • B800CYST5LC5 ()
  • B800CYST5LC0 ()

  • Total Volume: 5 Milliliter
CYST+ 5 LC

  • Multiple-type clinical chemistry analyte profile IVD, control

Validity Control Level 5 - B800170140

Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte IVD, control

MARK 5 NUVO 10 - 00038214001612

115V OCSI 10LPM OXYGEN CONCENTRATOR - EXTRA ACCESSORIES
NIDEK MEDICAL PRODUCTS, INC.
595NSH
In Commercial Distribution

  • 00038214001612 ()
595NSH

  • Stationary oxygen concentrator

MARK 5 NUVO 10 - 00038214001605

230V OCSI 10LPM OXYGEN CONCENTRATOR -- INDIA PLUG
NIDEK MEDICAL PRODUCTS, INC.
1005NI
In Commercial Distribution

  • 00038214001605 ()
1005NI

  • Stationary oxygen concentrator

MARK 5 NUVO 10 - 00038214001599

230V OCSI 10LPM OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE
NIDEK MEDICAL PRODUCTS, INC.
1005GC
In Commercial Distribution

  • 00038214001599 ()
1005GC

  • Stationary oxygen concentrator

MARK 5 NUVO LITE - 00038214001582

115V OCSI OXYGEN CONCENTRATOR -- FOR CANADA, FRENCH MANUAL
NIDEK MEDICAL PRODUCTS, INC.
525CA
In Commercial Distribution

  • 00038214001582 ()
525CA

  • Stationary oxygen concentrator

MARK 5 NUVO 10 - 00038214001575

230V OCSI 10LPM OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE, UK PLUG
NIDEK MEDICAL PRODUCTS, INC.
1005GCUK
In Commercial Distribution

  • 00038214001575 ()
1005GCUK

  • Stationary oxygen concentrator
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