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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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A.M.I.-dock Applicator Short 10mm - EAMIA101120

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 112
Not in Commercial Distribution

  • EAMIA101120 ()

  • Length: 392 Millimeter
  • Outer Diameter: 10 Millimeter
A10 112

  • Laparoscopic surgery handle

A.M.I.-dock Applicator Curved 5mm - EAMIA054930

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 493
Not in Commercial Distribution

  • EAMIA054930 ()

  • Length: 510 Millimeter
  • Outer Diameter: 5 Millimeter
A05 493

  • Laparoscopic surgery handle

A.M.I.-dock Applicator Short 5mm - EAMIA054920

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 multiple use applicator for the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A05 492
Not in Commercial Distribution

  • EAMIA054920 ()

  • Length: 392 Millimeter
  • Outer Diameter: 5 Millimeter
A05 492

  • Laparoscopic surgery handle

A.M.I.-dock Bluntdissect DLU 5mm - EAMIA052510

Loading unit for blunt dissection for A.M.I.-dock Applicator 5 mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
AMI Agency for Medical Innovations GmbH
A05 251
Not in Commercial Distribution

  • EAMIA052510 ()
  • EAMIA052511 ()

  • Length: 18 Millimeter
  • Outer Diameter: 4.5 Millimeter
A05 251

  • Dissection sponge

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

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
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