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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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Tinto INSM1 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.
BSB-3780-3
In Commercial Distribution

  • B502BSB378030 ()

  • Total Volume: 3 Milliliter
BSB-3780-3

  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
Tinto INI-1 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.
BSB-3779-7
In Commercial Distribution

  • B502BSB377970 ()

  • Total Volume: 7 Milliliter
BSB-3779-7

  • INI1 protein IVD, antibody
Tinto INI-1 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.
BSB-3779-3
In Commercial Distribution

  • B502BSB377930 ()

  • Total Volume: 3 Milliliter
BSB-3779-3

  • INI1 protein IVD, antibody
iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.3
In Commercial Distribution

  • B403IQS130 ()


  • Radiology picture archiving and communication system digital archive device
iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.2
In Commercial Distribution

  • B403IQS120 ()


  • Radiology picture archiving and communication system digital archive device
Titan™ Reverse Shoulder System The torx-25 screwdriver shaft with quick connect is used to advance the screw just before it is fully seated.
Ascension Orthopedics, Inc.
SCR096007201
In Commercial Distribution

  • M269SCR0960072011 ()
  • 10381780247371 ()

  • 9.80 in L
SCR-0960-072-01

  • Surgical screwdriver, reusable
Cadence Tibial Impactor Tip is attached to the tibial impactor handle and is used to seat the Tibial Tray Implant on the distal tibia.
Ascension Orthopedics, Inc.
10203100
Not in Commercial Distribution

  • M268102031001 ()
  • 10381780240280 ()


  • Orthopaedic implant/instrument assembling device
Screwdriver Handle is used in conjunction with the AO Hex Driver to assemble a AO Hex Screwdriver and is used to tighten locking screws
Ascension Orthopedics, Inc.
10204145
In Commercial Distribution

  • M268102041451 ()
  • 10381780240709 ()

  • 5.26in L x 1in diameter
10204145

  • Surgical instrument handle, non-torque-limiting
Tinto CA-125 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

  • B502BSB64010 ()
BSB 6401

  • Cancer antigen 125 (CA125) IVD, antibody
BOB.1 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.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB63850 ()
BSB 6385

  • B-cell specific octamer binding protein-1 (BOB-1) IVD, antibody
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