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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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NA - 07630031733122

CD Ø 1.3 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733122 ()

  • Outer Diameter: 1.3 Millimeter
026.0127

  • Dental implant internal thread shaping tool

BioPlex® 2200 - 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520138267

BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520138267 ()

  • 1 Each
12000657

  • Treponema pallidum reagin antibody IVD, reagent
  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 03610521185987

BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610521185987 ()

  • 1 Each
12006557

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Sherlock - 00801741124396

SHERLOCK 3CG FOR SR6 USB UPGRADE KIT W/ IFU CD
Bard Access Systems, Inc.
9770137
In Commercial Distribution

  • 00801741124396 ()
9770137

  • Central venous catheter navigation system, electrocardiographic/magnetic

CD - 06976289698013

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
21”*225 ft
In Commercial Distribution

  • 06976289698013 ()


  • Examination/treatment table paper

CD - 06976289697016

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
42”*30”
In Commercial Distribution

  • 06976289697016 ()


  • Patient gown, single-use

CD - 06976289696019

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
23”*36”
In Commercial Distribution

  • 06976289696019 ()


  • Absorbent underpad, non-antimicrobial, single-use

CD - 06976289695012

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
33*45cm
In Commercial Distribution

  • 06976289695012 ()


  • Dental bib

M SERIES - 00847946003609

Defibrillator ,MAIN BSC-4 BIPH/SPO2/AC/PC/EL/RC/SM/CD
Zoll Medical Corporation
40010211100103010
In Commercial Distribution

  • 00847946003609 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
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