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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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BEQ HMOD 30000 BEQ-RF32 Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 6604
Not in Commercial Distribution

  • 00607567202580 ()
701052163

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000 USA Adult Quadrox Softshell venous Reser. 1900ml with connector Gas Filter
DATASCOPE CORP.
BEQ-TOP 47501
Not in Commercial Distribution

  • 00607567207561 ()
709000031

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000-USA Pediatric Quadrox iD
DATASCOPE CORP.
BEQ-TOP 8512
In Commercial Distribution

  • 00607567213449 ()
709000624

  • Cardiopulmonary bypass system blood tubing set
No Description
IT-V Medizintechnik GmbH
P10107-653
Not in Commercial Distribution

  • 09120074396531 ()


  • Radiological whole-body positioner
No Description
IT-V Medizintechnik GmbH
P10107-652
Not in Commercial Distribution

  • 09120074396524 ()


  • Radiological whole-body positioner
N/A
Cochlear Bone Anchored Solutions AB
92143
In Commercial Distribution

  • 09321502019644 ()
92143

  • General external orthopaedic fixation system implantation kit, reusable
NavPRO One branded Sentiero Advanced
PATH medical GmbH
100360-NPO
In Commercial Distribution

  • 04260223143311 ()


  • Evoked-potential audiometer
AuDX PRO branded Sentiero
PATH medical GmbH
100098-AUP
In Commercial Distribution

  • 04260223143298 ()


  • Evoked-potential audiometer
The SKORE Thin Condoms with flavors - SKORE SKINTHIN condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, silicone oil with Zeus odor masker male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE SKINTHIN natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE SKINTHIN
In Commercial Distribution

  • 08906007135528 ()
  • 08906007135511 ()
  • 08906007135535 ()
  • 08906007135542 ()


  • Basic male condom, Hevea-latex
The SKORE Thin Condoms with Flavors - SKORE NOTHING Chocolate condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, Chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE NOTHING Chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE NOTHING Chocolate
In Commercial Distribution

  • 08906007135481 ()
  • 08906007135474 ()
  • 08906007135498 ()
  • 08906007135504 ()


  • Basic male condom, Hevea-latex
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