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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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EarQ - 05711584072660

G40, MINIRITE T 312 2.4G C044 EARQ
Oticon A/S
177340
In Commercial Distribution

  • 05711584072660 ()


  • Air-conduction hearing aid, receiver-in-the-ear

EarQ - 05711584072653

G40, MINIRITE T 312 2.4G C093 EARQ
Oticon A/S
177339
In Commercial Distribution

  • 05711584072653 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Gonochek®-II Reagent Tubes - 00863251000218

Gonochek®-II is intended for the use in the detection of prolyliminopeptidase, gammaglutamylaminopeptidase, and beta-galactosidase from colonies grown on selective media, to aid in the presumptive identification of Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica and Moraxella (Branhamella) catarrhalis. Gonochek®-II consists of a reagent tube which contains three chromogenic substrates for use in the detection of three preformed enzymes, prolyliminopeptidase, gamma-glutamyl-aminopeptidase, and beta-galactosidase. These three enzymes have been shown to be accurate in identifying N.gonorrhoeae, N. meningitidis and N. lactamica respectively. The red cap of the Reagent Tube contains a color developer (diazo dye).
E-Y Laboratories, Inc.
13-003-25
In Commercial Distribution

  • 00863251000218 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

EarQ - 05711584072639

G40, MINIRITE T 312 2.4G C092 EARQ
Oticon A/S
177337
In Commercial Distribution

  • 05711584072639 ()


  • Air-conduction hearing aid, receiver-in-the-ear

EarQ - 05711584072585

G50, MINIRITE T 312 2.4G C093 EARQ
Oticon A/S
177332
In Commercial Distribution

  • 05711584072585 ()


  • Air-conduction hearing aid, receiver-in-the-ear

EarQ - 05711584072561

G50, MINIRITE T 312 2.4G C092 EARQ
Oticon A/S
177330
In Commercial Distribution

  • 05711584072561 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Reveal - 05711584072530

G30, MINIRITE T 312 2.4G C094 REVEAL
Oticon A/S
177316
In Commercial Distribution

  • 05711584072530 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Reveal - 05711584072516

G30, MINIRITE T 312 2.4G C093 REVEAL
Oticon A/S
177314
In Commercial Distribution

  • 05711584072516 ()


  • Air-conduction hearing aid, receiver-in-the-ear

In Reach - 00863152000331

Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-230
In Commercial Distribution

  • 00863152000331 ()


  • Limited-view-field CT system

Reveal - 05711584072493

G30, MINIRITE T 312 2.4G C092 REVEAL
Oticon A/S
177311
In Commercial Distribution

  • 05711584072493 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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