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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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No Description
Berman Instruments LLC
GC045
Not in Commercial Distribution

  • 00810060722848 ()


  • Dental restoration carver, resin
No Description
Sonova AG
(velvet black)
In Commercial Distribution

  • 07613389718188 ()
050-1094-P867

  • Air-conduction hearing aid, receiver-in-canal
No Description
Sonova AG
(silver gray)
In Commercial Distribution

  • 07613389718171 ()
050-1094-P667

  • Air-conduction hearing aid, receiver-in-canal
No Description
Sonova AG
(sand beige)
In Commercial Distribution

  • 07613389718164 ()
050-1094-P167

  • Air-conduction hearing aid, receiver-in-canal
Verification of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose and lactate performance on the instrument.
Diamond Diagnostics Inc.
DD-92900
In Commercial Distribution

  • 00811403014798 ()


  • Multiple blood gas analyte IVD, control
The Ammonia Standards are intended for the calibration of ammonia assays.
POINTE SCIENTIFIC, INC.
A7553-STD500
In Commercial Distribution

  • 00811727010278 ()
A7553-STD500

  • Ammonia IVD, calibrator
No Description
HIOSSEN, INC.
FNLHYD05
In Commercial Distribution

  • 00810126042019 ()


  • Dental implant suprastructure, temporary, preformed, single-use
5mL/bottle. Concentration: 1000 ng/mL of Secobarbital.
LIN-ZHI INTERNATIONAL, INC.
0145
In Commercial Distribution

  • B07601450 ()
0145

  • Barbiturate IVD, calibrator
5mL/bottle. Concentration: 1000 ng/mL of Oxazepam.
LIN-ZHI INTERNATIONAL, INC.
0135
In Commercial Distribution

  • B07601350 ()
0135

  • Benzodiazepine group IVD, calibrator
PROXIMEL BASIC 9x9 5/BX
HARTMANN USA, INC.
15713116
In Commercial Distribution

  • 20612553023784 ()
  • 10612553023787 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
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