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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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truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device
CUTERA, INC.
truSculpt 5 RF handpiece
In Commercial Distribution

  • 00816722022486 ()


  • Radio-frequency skin contouring system applicator, monopolar
Cytokeratin 5 and Cytokeratin 14 is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB66300 ()
BSB 6630

  • Cytokeratin IVD, antibody
Cytokeratin 5 and Cytokeratin 14 is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB66290 ()
BSB 6629

  • Cytokeratin IVD, antibody
Cytokeratin 5 and Cytokeratin 14 is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB66280 ()
BSB 6628

  • Cytokeratin IVD, antibody
Cytokeratin 5 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB66160 ()
BSB 6616

  • Cytokeratin IVD, antibody
Cytokeratin 5 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB66150 ()
BSB 6615

  • Cytokeratin IVD, antibody
Cytokeratin 5 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB66140 ()
BSB 6614

  • Cytokeratin IVD, antibody
Anti-CK 5 & 6 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB66090 ()
BSB 6609

  • Cytokeratin IVD, antibody
Anti-CK 5 & 6 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB66080 ()
BSB 6608

  • Cytokeratin IVD, antibody
Anti-CK 5 & 6 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB66070 ()
BSB 6607

  • Cytokeratin IVD, antibody
Cytokeratin 5 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB66030 ()
BSB 6603

  • Cytokeratin IVD, control
Tinto Cytokeratin 5 antibody is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB65990 ()
BSB 6599

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 5 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB65980 ()
BSB 6598

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 5 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB65970 ()
BSB 6597

  • Cytokeratin IVD, antibody
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution

  • 10385083000503 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
No Description
Biomet Orthopedics, LLC
29409
In Commercial Distribution

  • 00888480266099 ()
29409

  • Orthopaedic implant-instrument extension adaptor, reusable
No Description
ROCKWELL MEDICAL, INC.
R-100
In Commercial Distribution

  • 00814963021121 ()
  • 10814963021128 ()
R-100

  • Haemodialysis concentrate
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