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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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DeRoyal - 00749756374361

CA OF MI #11642 ILR IMPLANT PACK
DEROYAL INDUSTRIES, INC.
89-10714
In Commercial Distribution

  • 50749756374366 ()
  • 00749756374361 ()
89-10714

  • General surgical procedure kit, non-medicated, single-use

IHC - 00810170550683

TAG-72/CA 72-4, Clone B72.3, 6ml (Manual)
Slmp, LLC
(BTO) Manual TAG-72/CA 72-4 (B72.3) Antibody (6ml)
In Commercial Distribution

  • 00810170550683 ()
MM137-6

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody

CS 7600 - 60889971068408

CS7600 Imaging System for US, CA, Brazil
CARESTREAM HEALTH, INC.
CS 7600
In Commercial Distribution

  • 60889971068408 ()
1068402

  • Dental computed radiography digital imaging scanner

Rabbit Monoclonal Anti-Human CA 125 Antibody, EP48 - 00810113061405

Rabbit Monoclonal Anti-Human CA 125 (48), concentrated
Epitomics Inc.
AC-0046BULK
In Commercial Distribution

  • 00810113061405 ()


  • Cancer antigen 125 (CA125) IVD, antibody

Ventlab - 30889483271036

PVC Anesthesia Mask #2, Pediatric, 150/CA
VENTLAB, LLC
812-0007-01
Not in Commercial Distribution

  • 30889483271036 ()
812-0007-01

  • Anaesthesia face mask, single-use

Ventlab - 30889483271012

PVC Anesthesia Mask #1, Infant, 200/CA
VENTLAB, LLC
812-0006-01
In Commercial Distribution

  • 30889483271012 ()
812-0006-01

  • Anaesthesia face mask, single-use

Refractive Cannulae - 35056030400477

25g x 7/8" Lasik Irrig Ca
STERIMEDIX LIMITED
M2822-02/10
In Commercial Distribution

  • 25056030400296 ()
  • 35056030400477 ()
M2822

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Insulin Syringes - 50382903247023

SYRINGE 0.3ML 29GA 1/2IN 200BX CA
BECTON, DICKINSON AND COMPANY
324702
Not in Commercial Distribution

  • 10382903247025 ()
  • 50382903247023 ()
  • 80382903247024 ()

  • Needle Gauge: 29 Gauge
  • Length: 12.77 Millimeter
324702

  • Insulin syringe/needle, basic

Curaplex - 00810071631283

MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen

Curaplex - 00810071631160

TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
BOUND TREE MEDICAL, LLC
301-160EA
In Commercial Distribution

  • 00810071630767 ()
  • 00810071631160 ()
301-160EA

  • Non-rebreathing valve, single-use
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