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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 - 07613252516927

ZEISS PENTERO MICROSKOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-075-000
In Commercial Distribution

  • 07613252516927 ()
7700-075-000

  • Multi-purpose stereotactic surgery system

Healgen - 00816490020950

14 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG /pH
Healgen Scientific Limited Liability Company
HCDOAV-1144A3
In Commercial Distribution

  • 20816490020954 ()
  • 10816490020957 ()
  • 00816490020950 ()
HCDOAV-1144A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490020042

13 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-2135
In Commercial Distribution

  • 20816490020046 ()
  • 10816490020049 ()
  • 00816490020042 ()
HCDOAV-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

HydroMark - 00841911101505

HydroMARK Breast Biopsy Site Marker
DEVICOR MEDICAL PRODUCTS, INC.
4010-03-09-T1
In Commercial Distribution

  • 10841911101502 ()
  • 00841911101505 ()

  • Needle Gauge: 9 Gauge


  • Radiological image marker, implantable

AMC - 00849593013796

Cable,ECG,Shielded,3 Lead,AAMI,DS com, 10'
Advantage Medical Electronics, LLC
CB-73340R
In Commercial Distribution

  • 00849593013796 ()


  • Electrical-only medical device connection cable, reusable

3-LD Set, PINCH to TWIN, A, 29, TEL COM - 00840828148764

3-LD Set, PINCH to TWIN, A, 29, TEL COM
CURBELL MEDICAL PRODUCTS, INC.
LW-3300029/3AT
In Commercial Distribution

  • 00840828148764 ()
9233

  • Electrocardiographic lead set, reusable

UTS Hip Stem - 04711605582377

UTS Neck trial, high offset, #12~#14
UNITED ORTHOPEDIC CORP.
9116-5024
In Commercial Distribution

  • 04711605582377 ()

  • high offset, #12~#14
9116-5024

  • Columbia agar culture medium IVD, 5% horse blood

UTS Hip Stem - 04711605582360

UTS Neck trial, high offset, #9~#11
UNITED ORTHOPEDIC CORP.
9116-5023
In Commercial Distribution

  • 04711605582360 ()

  • high offset, #9~#11
9116-5023

  • Columbia agar culture medium IVD, 5% horse blood

UTS Hip Stem - 04711605582353

UTS Neck trial, high offset, #5~#8
UNITED ORTHOPEDIC CORP.
9116-5022
In Commercial Distribution

  • 04711605582353 ()

  • high offset, #5~#8
9116-5022

  • Columbia agar culture medium IVD, 5% horse blood

UTS Hip Stem - 04711605582346

UTS Neck trial, high offset, #1~#4
UNITED ORTHOPEDIC CORP.
9116-5021
In Commercial Distribution

  • 04711605582346 ()

  • high offset, #1~#4
9116-5021

  • Columbia agar culture medium IVD, 5% horse blood
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