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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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ACCUTRON, INC.
34070-CUSTOM
Not in Commercial Distribution

  • 90813830020048 ()
34070-CUSTOM

  • Nitrous oxide quick-connect coupling, male
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0592
In Commercial Distribution

  • 30607915120499 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
Handpiece for Proxeo ULTRA
W & H Dentalwerk Bürmoos GmbH
30327000
Not in Commercial Distribution

  • J021303270000 ()
  • J021303270001 ()


  • Dental ultrasonic surgical system handpiece
Sub Q infusion set. Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
71-060-2738
Not in Commercial Distribution

  • 05705244004672 ()
  • 05705244009868 ()
  • 05705244004689 ()

  • Length: 60 Centimeter
  • Depth: 8 Millimeter
  • Angle: 90 degree


  • Electric infusion pump administration set, single-use
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9040
Not in Commercial Distribution

  • 08806387890409 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9034
Not in Commercial Distribution

  • 08806387890348 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9033
Not in Commercial Distribution

  • 08806387890331 ()


  • Endodontic obturation system
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240961
In Commercial Distribution

  • 00845533001700 ()
Q240961

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240241
In Commercial Distribution

  • 00845533001694 ()
Q240241

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240181
In Commercial Distribution

  • 00845533001687 ()
Q240181

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
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