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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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FirstBurst Urine Collection Device v2 - B714C060005850

For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
2.0
In Commercial Distribution

  • B714C060005 ()
  • B714C060005850 ()
C06-0005-85

  • Non-evacuated urine specimen container IVD, no additive

FirstBurst Urine Collection Device - B714C060003200

For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
1.0
In Commercial Distribution

  • B714C060003200 ()
  • B714C060003 ()
C06-0003-20

  • Non-evacuated urine specimen container IVD, no additive

A.M.I.-dock Applicator Standard 5mm - AMIA054910

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic carrier for the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A05 491
Not in Commercial Distribution

  • AMIA054910 ()

  • Length: 510 Millimeter
  • Outer Diameter: 5 Millimeter
A05 491

  • Laparoscopic surgery handle

SnoreLogic - 15035883000917

No Description
PASSION FOR LIFE HEALTHCARE (UK) LIMITED
SMAN-USA-001-V1
In Commercial Distribution

  • 15035883000917 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

A.M.I. HAL-II Electronic System - EAMIAHE2030

Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System. The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal. Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa.
AMI Agency for Medical Innovations GmbH
AHE 203
Not in Commercial Distribution

  • EAMIAHE2030 ()

  • Weight: 3.2 Kilogram
  • Depth: 260 Millimeter
  • Height: 140 Millimeter
  • Width: 385 Millimeter
AHE 203

  • Noninvasive vascular ultrasound system

A.M.I. Flexible Wire Guide - EAMIGBC3630

Wire guide for cutting a migrated silicone gastric band
AMI Agency for Medical Innovations GmbH
GBC 363
Not in Commercial Distribution

  • EAMIGBC3630 ()

  • Length: 1000 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Lumen/Inner Diameter: 0.8 Millimeter
GBC 363

  • Open-surgery dissector

A.M.I. FasciaCutter Disposable Instrument - EAMIAFC1000

The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction with an A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision.
AMI Agency for Medical Innovations GmbH
AFC 100
Not in Commercial Distribution

  • EAMIAFC1000 ()

  • Outer Diameter: 13 Millimeter
  • Length: 195 Millimeter
AFC 100

  • Scalpel, single-use

A.M.I.-dock Applicator Standard 10mm - EAMIA101110

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic multiple use carrier to operate the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A10 111
Not in Commercial Distribution

  • EAMIA101110 ()

  • Length: 500 Millimeter
  • Outer Diameter: 10 Millimeter
A10 111

  • Laparoscopic surgery handle

Turtlebrace - 20628634832145

The brace is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Velcro closure separate. Size medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Wrist Pediatric
In Commercial Distribution

  • 20628634832145 ()

  • PED M for Pediatric Medium
  • PED L for Pediatric Large
HBPP-02,HBPP-03

  • Custom-made upper-limb orthosis

Turtlebrace - 20628634832084

The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with velcro closure. Size medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Wrist Pediatric with velcro closure
In Commercial Distribution

  • 20628634832084 ()

  • PED M for Pediatric Medium
  • PED L for Pediatric Large
TBPPV-02,TBPPV-03

  • Custom-made upper-limb orthosis
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