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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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Automated IFA Processor
Aesku.Systems GmbH & Co. KG
HELMED® IFA PROCESSOR KIT
Not in Commercial Distribution

  • 42601861205007 ()
HEL-1000

  • Multi-modality clinical specimen analysis system IVD
No Description
MONOBIND, INC.
IN006-2
In Commercial Distribution

  • 00816870020082 ()
IN006-2

  • Multi-modality clinical specimen analysis system IVD
No Description
MONOBIND, INC.
IN013
In Commercial Distribution

  • 00816870020068 ()
IN013

  • Enzyme immunoassay (EIA) analyser IVD
No Description
MONOBIND, INC.
IN009
In Commercial Distribution

  • 00816870020051 ()
IN009

  • Enzyme immunoassay (EIA) analyser IVD
Lyric programming wand
Sonova AG
058-0151
In Commercial Distribution

  • 07613389392746 ()
058-0151

  • Hearing aid wireless-fitting computer-aided set
No Description
Roche Diagnostics GmbH
08463662001
In Commercial Distribution

  • 07613336158784 ()
08463662001

  • Multi-modality clinical specimen analysis system IVD
No Description
Roche Diagnostics GmbH
08763640001
In Commercial Distribution

  • 07613336164846 ()
08763640001

  • Multi-modality clinical specimen analysis system IVD
Bolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00500R
In Commercial Distribution

  • B35000500R0 ()
00500R

  • Enzyme immunoassay (EIA) analyser IVD
Bolt EIA
Gold Standard Diagnostics Corporation
00500
In Commercial Distribution

  • B350005000 ()
00500

  • Enzyme immunoassay (EIA) analyser IVD
ThunderBolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00300R
In Commercial Distribution

  • B35000300R0 ()
00300R

  • Enzyme immunoassay (EIA) analyser IVD
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