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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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PEARSON DENTAL SUPPLIES, INC.
B310374
In Commercial Distribution

  • D724B3103741 ()


  • Silicone dental impression material
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C140B
In Commercial Distribution

  • B066C140B1 ()
  • B066C140B5 ()
  • B066C140B4 ()
  • B066C140B2 ()
  • B066C140B0 ()
  • B066C140B3 ()
C140B

  • Non-ISO80369-standardized small-bore linear connector, single-use
3100 Operating Room Table Pad 2 Thick (Set Of 2). 2860 High Density Foam Non-Latex With 'Lectrolite Conductive Covering. With Velcro Kit
FUTURE HEALTH CONCEPTS, INC.
BB3100
In Commercial Distribution

  • B337BB31001 ()
BB3100

  • Stretcher mattress
A non-sterile, long and narrow flexible band of material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects.
Medique Products
65699
In Commercial Distribution

  • 50347682656992 ()
  • 00347682656997 ()
65699

  • Dressing-fixation skin adhesive tape, non-silicone
No Description
Bird & Cronin, LLC
90003480
In Commercial Distribution

  • 00610570188154 ()


  • Hot/cold therapy pack, single-use
Syringe cap and battery cap are accessories for insulin pump use. They helps the insulin pump used properly.
SOOIL DEVELOPMENT CO.,LTD
Syringe and battery cap
In Commercial Distribution

  • 08809220580994 ()


  • Ambulatory insulin infusion pump, electronic
1 Inner Box - 10 Pouches / Inner Box, 10 Packs / Pouch. 4 Each / Pack
BIOMEDICAL LIFE SYSTEMS, INC.
EERC200M
In Commercial Distribution

  • 10857771003597 ()
EERC200M

  • Transcutaneous electrical stimulation electrode, single-use
Instruments, Dental Hand
Kulzer GmbH
66001970
In Commercial Distribution

  • J014660019700 ()
66001970

  • Syringe dispensing gun, reusable
The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 2 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 2 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
PTH10609
In Commercial Distribution

  • 05055273219821 ()
PTH10609

  • Parathyroid hormone (PTH) IVD, control
The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 2 (AMH10514) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10514
In Commercial Distribution

  • 05055273217780 ()
AMH10514

  • Anti-Mullerian hormone (AMH) IVD, control
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