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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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Foreign Body Forceps, 7 Fr.
Karl Storz GmbH & Co. KG
27175A
In Commercial Distribution

  • 04048551081280 ()
27175A

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Foreign Body Forceps, 28 cm
Karl Storz GmbH & Co. KG
27071TJ
In Commercial Distribution

  • 04048551079119 ()
27071TJ

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Foreign Body Forceps, 40 cm
Karl Storz GmbH & Co. KG
27034FK
In Commercial Distribution

  • 04048551075210 ()
27034FK

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter. This Device Identification is for a kit that is shipped without a charger.
Tatch Inc.
WSWW-RE-K-N-V02-BLO
In Commercial Distribution

  • 00860007837029 ()


  • Polysomnograph
RADIFOCUS Obturator
TERUMO CORPORATION
XX902
In Commercial Distribution

  • 54987350774618 ()
  • 34987350774614 ()
  • 04987350774613 ()

  • Outer Diameter: 3.0 Millimeter
  • Length: 25 Centimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050925A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX901
In Commercial Distribution

  • 54987350774595 ()
  • 34987350774591 ()
  • 04987350774590 ()

  • Length: 10 Centimeter
  • Outer Diameter: 3.0 Millimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050910A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX802
In Commercial Distribution

  • 54987350774571 ()
  • 34987350774577 ()
  • 04987350774576 ()

  • Length: 25 Centimeter
  • Outer Diameter: 2.7 Millimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050825A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX801
In Commercial Distribution

  • 54987350774557 ()
  • 34987350774553 ()
  • 04987350774552 ()

  • Length: 10 Centimeter
  • Outer Diameter: 2.7 Millimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050810A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX702
In Commercial Distribution

  • 34987350774539 ()
  • 04987350774538 ()
  • 54987350774533 ()

  • Length: 25 Centimeter
  • Outer Diameter: 2.4 Millimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050725A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX701
In Commercial Distribution

  • 54987350774519 ()
  • 34987350774515 ()
  • 04987350774514 ()

  • Those Clinically Relevant Size are relative to the compatible sheath.
  • Length: 10 Centimeter
  • Outer Diameter: 2.4 Millimeter
XX*RF050710A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX602
In Commercial Distribution

  • 54987350774496 ()
  • 34987350774492 ()
  • 04987350774491 ()

  • Those Clinically Relevant Size are relative to the compatible sheath.
  • Outer Diameter: 2.0 Millimeter
  • Length: 25 Centimeter
XX*RF050625A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX601
In Commercial Distribution

  • 34987350774478 ()
  • 04987350774477 ()
  • 54987350774472 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 10 Centimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050610A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX502
In Commercial Distribution

  • 34987350774454 ()
  • 04987350774453 ()
  • 54987350774458 ()

  • Length: 25 Centimeter
  • Outer Diameter: 1.7 Millimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050525A

  • Vascular catheter introduction set, nonimplantable
RADIFOCUS Obturator
TERUMO CORPORATION
XX501
In Commercial Distribution

  • 34987350774430 ()
  • 04987350774439 ()
  • 54987350774434 ()

  • Outer Diameter: 1.7 Millimeter
  • Length: 10 Centimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
XX*RF050510A

  • Vascular catheter introduction set, nonimplantable
ALT LNR TRL 10° FC G8 36
Exactech, Inc.
01-031-48-0836
In Commercial Distribution

  • 10885862555571 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0836

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G8 32
Exactech, Inc.
01-031-48-0832
In Commercial Distribution

  • 10885862555564 ()

  • Angle: 10 degree
  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
01-031-48-0832

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G7 40
Exactech, Inc.
01-031-48-0740
In Commercial Distribution

  • 10885862555533 ()

  • Angle: 10 degree
  • Lumen/Inner Diameter: 40 Millimeter
  • Lateral angle of the face with respect to base plane
01-031-48-0740

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G7 36
Exactech, Inc.
01-031-48-0736
In Commercial Distribution

  • 10885862555526 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 36 Millimeter
01-031-48-0736

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G7 32
Exactech, Inc.
01-031-48-0732
In Commercial Distribution

  • 10885862555519 ()

  • Angle: 10 degree
  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 32 Millimeter
01-031-48-0732

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G6 40
Exactech, Inc.
01-031-48-0640
In Commercial Distribution

  • 10885862555489 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 40 Millimeter
01-031-48-0640

  • Acetabulum prosthesis trial, prefabricated, reusable
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