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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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ALT LNR TRL 10° FC G6 32
Exactech, Inc.
01-031-48-0632
In Commercial Distribution

  • 10885862555465 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0632

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G5 36
Exactech, Inc.
01-031-48-0536
In Commercial Distribution

  • 10885862555427 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0536

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G5 32
Exactech, Inc.
01-031-48-0532
In Commercial Distribution

  • 10885862555410 ()

  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 32 Millimeter
  • Angle: 10 degree
01-031-48-0532

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G4 36
Exactech, Inc.
01-031-48-0436
In Commercial Distribution

  • 10885862555380 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 36 Millimeter
01-031-48-0436

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G4 32
Exactech, Inc.
01-031-48-0432
In Commercial Distribution

  • 10885862555373 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0432

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G3 32
Exactech, Inc.
01-031-48-0332
In Commercial Distribution

  • 10885862555335 ()

  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 32 Millimeter
  • Angle: 10 degree
01-031-48-0332

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G3 28
Exactech, Inc.
01-031-48-0328
In Commercial Distribution

  • 10885862555328 ()

  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 28 Millimeter
  • Angle: 10 degree
01-031-48-0328

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G2 32
Exactech, Inc.
01-031-48-0232
In Commercial Distribution

  • 10885862555304 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 32 Millimeter
01-031-48-0232

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G1 28
Exactech, Inc.
01-031-48-0128
In Commercial Distribution

  • 10885862555274 ()

  • Angle: 10 degree
  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 28 Millimeter
01-031-48-0128

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G8 40
Exactech, Inc.
01-031-48-0840
In Commercial Distribution

  • 10885862555588 ()

  • Angle: 10 degree
  • Lumen/Inner Diameter: 40 Millimeter
  • Lateral angle of the face with respect to base plane
01-031-48-0840

  • Femoral head prosthesis trial
The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711197
Not in Commercial Distribution

  • 10816765013653 ()
  • 00816765013656 ()

  • Outer Diameter: 2.5 Millimeter
  • Width: 3 Centimeter
  • Length: 230 Centimeter
00711197

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711159
Not in Commercial Distribution

  • 10816765012854 ()
  • 00816765012857 ()

  • Width: 3 Centimeter
  • Length: 230 Centimeter
  • Outer Diameter: 2.8 Millimeter
00711159

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711158
Not in Commercial Distribution

  • 10816765012717 ()
  • 00816765012710 ()

  • Width: 3 Centimeter
  • Outer Diameter: 2.8 Millimeter
  • Length: 230 Centimeter
00711158

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711200
In Commercial Distribution

  • 10724995220058 ()
  • 00724995220051 ()

  • Outer Diameter: 2.5 Millimeter
  • Width: 3 Centimeter
  • Length: 230 Centimeter
00711200

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711197
In Commercial Distribution

  • 10724995182851 ()
  • 00724995182854 ()
  • 00816765013656 ()

  • Width: 3 Centimeter
  • Outer Diameter: 2.5 Millimeter
  • Length: 230 Centimeter
00711197

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711159
In Commercial Distribution

  • 10724995182721 ()
  • 00724995182724 ()
  • 00816765012857 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 230 Centimeter
  • Width: 3 Centimeter
00711159

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711158
In Commercial Distribution

  • 10724995182714 ()
  • 00724995182717 ()
  • 00816765012710 ()

  • Outer Diameter: 2.8 Millimeter
  • Width: 3 Centimeter
  • Length: 230 Centimeter
00711158

  • Gastrointestinal/airway foreign body retrieval basket, single-use
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
The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Sense Technology, Inc.
G3
In Commercial Distribution

  • 10855341008003 ()
  • 00855341008006 ()


  • Joint/spinal manipulator, electronic
The Roth Net retriever is used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711170
Not in Commercial Distribution

  • 10816765013516 ()
  • 00816765013519 ()

  • Length: 230 Centimeter
  • Width: 3 Centimeter
  • Outer Diameter: 2.5 Millimeter
00711170

  • Gastrointestinal/airway foreign body retrieval basket, single-use
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