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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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ANA Speckled Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2022 (2)
In Commercial Distribution

  • M7490202221 ()
2022 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control
No Description
Chongqing Yeasn Science & Technology Co.,Ltd.
CCQ1100
Not in Commercial Distribution

  • 06971922131377 ()
CCQ11/2

  • Automated lensmeter
Rotary carbide instrument for dental application
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
500MAX2-F8-01
In Commercial Distribution

  • 17291046616427 ()
NEOMAX 2

  • Carbide dental bur, reusable
TRAY STERILIZATION HOLDS 30
Bausch & Lomb Incorporated
E7416 2
In Commercial Distribution

  • 00757770420674 ()
E7416 2

  • Instrument tray, reusable
BONECUTTER OSTEOTOME HANDSET
ORTHOFIX SRL
1
In Commercial Distribution

  • 18056099649995 ()
OHB300/2

  • Hard/soft-tissue ultrasonic surgical system
CEMENT REMOVAL HANDSET
ORTHOFIX SRL
1
In Commercial Distribution

  • 18056099649988 ()
OH300/2

  • Hard/soft-tissue ultrasonic surgical system
No Description
Bion Enterprises, Ltd.
RG-M7612-D
Not in Commercial Distribution

  • B110RGM7612D0 ()
RG-M7612-D

  • Bullous pemphigoid antigen 2 (BPAG2) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07108133162
In Commercial Distribution

  • 07613336183182 ()
07108133162

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control
No Description
Roche Diagnostics GmbH
09366989190
In Commercial Distribution

  • 07613336183014 ()
09366989190

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control
Herpes-2 IgG (HSV2) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733034
In Commercial Distribution

  • 00842768022838 ()
10733034

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
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