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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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No Description
Biomet Orthopedics, LLC
110017306
In Commercial Distribution

  • 00880304812871 ()

  • 2.9 mm
110017306

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110010384
In Commercial Distribution

  • 00880304812864 ()

  • 2.9 MM
110010384

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110010379
In Commercial Distribution

  • 00880304812833 ()

  • 2.9 mm
110010379

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
DERMARITE INDUSTRIES LLC
31110
In Commercial Distribution

  • 00714196391704 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
31460
In Commercial Distribution

  • 00714196391681 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
00312E
In Commercial Distribution

  • 00714196391605 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
00219E
In Commercial Distribution

  • 00714196391582 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
31240
In Commercial Distribution

  • 00714196391568 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
31460
In Commercial Distribution

  • 00714196314604 ()
  • 01714196314603 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
00312E
In Commercial Distribution

  • 00714196312662 ()
  • 01714196312661 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
31240
In Commercial Distribution

  • 00714196312402 ()
  • 01714196312401 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
31110
In Commercial Distribution

  • 00714196311108 ()
  • 01714196311107 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
DERMARITE INDUSTRIES LLC
00219E
In Commercial Distribution

  • 00714196219442 ()
  • 01714196219441 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Reusable Probe with Irrigation Holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6211
Not in Commercial Distribution

  • 00607915117139 ()

  • Length: 45 Centimeter
  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
Reusable Probe with Pool Tip.
APPLIED MEDICAL RESOURCES CORPORATION
C6205
Not in Commercial Distribution

  • 00607915117085 ()

  • Length: 33 Centimeter
  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
BEQ-HMOD 70000-USA Adult Quadrox iD, Better Bladder 3/8, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Gas Filter
DATASCOPE CORP.
BEQ-TOP 13505
Not in Commercial Distribution

  • 00607567205536 ()
701065817

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000-USA Pediatric Quadrox Softshell Venous Reser 800 ml Better Bladder BEQ-RF32 RotaFlow CDI Sat Cell 1/4" Blood Microfilter Systes Prebypass filter w/o Vent Posous Media Gas Filter Temperature Probe
DATASCOPE CORP.
BEQ-TOP 31000
Not in Commercial Distribution

  • 00607567205192 ()
701052843

  • Cardiopulmonary bypass system blood tubing set
BO-VHK 31000 Venous Res. Pediatric (MACE), BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 16403
Not in Commercial Distribution

  • 00607567205130 ()
701065315

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000 Softshell venous reser Better Bladder BEQ-RF32 CDI Sat Cell Blood Microfilter System Prebypass Filter
DATASCOPE CORP.
BEQ-TOP 35300
Not in Commercial Distribution

  • 00607567203075 ()
70105506

  • Cardiopulmonary bypass system blood tubing set
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
The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry 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 Strawberry 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 Strawberry
In Commercial Distribution

  • 08906007135443 ()
  • 08906007135436 ()
  • 08906007135450 ()
  • 08906007135467 ()


  • Basic male condom, Hevea-latex
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