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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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GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
LAP
In Commercial Distribution

  • 08437018413089 ()

  • Length: 514 Millimeter
  • Weight: 182 Gram
  • Width: 40 Millimeter
  • Height: 40 Millimeter
IC-1170

  • Intraoperative gamma radiation detection system probe, reusable
GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
STD
In Commercial Distribution

  • 08437018413072 ()

  • Length: 255 Millimeter
  • Weight: 162 Gram
  • Width: 40 Millimeter
  • Height: 40 Millimeter
IC-1150

  • Intraoperative gamma radiation detection system probe, reusable
A control handle for a flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. The device is constructed of a flexible metal coil and plastic tube whose distal end is equipped with a helical shaped basket which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.
HOBBS MEDICAL, INC.
4850
In Commercial Distribution

  • M84948500 ()
4850

  • Flexible endoscopic tissue manipulation forceps, reusable
The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
2200A-47E
Not in Commercial Distribution

  • 00857334004286 ()

  • Length: 47 Centimeter
2200A-47E

  • Vagus nerve electrical stimulation system lead
Applier is an accessory used during minimally invasive surgery. The Applier is a standard cannula with a trigger that is used to introduce Virtual Ports' devices (EndoGrab, EndoLift or EndoClear) into the internal operating cavity via a port. After introduction into the operating cavity, the devices are applied to an organ and then anchored to the internal abdominal wall. The Applier is then removed, and the port remains available for use by other instruments. When the use of Virtual Port's devices is completed, the Applier is used for their retrieval from the internal operating cavity.
VIRTUAL PORTS LTD
AP045A
In Commercial Distribution

  • M660AP045A0 ()

  • Length: 45 Centimeter
AP045A

  • Internally-anchored endoscopic retractor applier
The Capture Screw System is comprised of headless screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The headless screw is a cannulated, dual-thread headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 – 34mm. The quick snap screw is a snap-off solid screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8-22mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPHLESSIMP
Not in Commercial Distribution

  • M268CAPHLESSIMP1 ()
  • 10381780064510 ()
CAPHLESSIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S.BLOCK N.LOCK NEO BIOTECH IS h.2 TiN
In Commercial Distribution

  • 08059224116792 ()
002NBT2R

  • Dental implant suprastructure, permanent, preformed
The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint, as well as corresponding instrumentation. The radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal. It is manufactured from cast CoCr alloy. The carpal component is a titanium plate which is fixed into the carpal bones with a cemented central peg and two titanium screws. Instrumentation is provided to assist in the surgical implantation.
Ascension Orthopedics, Inc.
UNI2SET
Not in Commercial Distribution

  • M268UNI2SET0 ()
  • 10381780064336 ()

  • 21.5 in L x 10.3 in W
UNI2SET

  • Total wrist prosthesis
Wireless Hand Control, EG1A
Anspach Effort, The
WIRELESS-HC
In Commercial Distribution

  • 00845384018759 ()
WIRELESS-HC

  • Surgical power tool hand-switch
This re-usable device is an accessory for ZEISS phaco systems. It is used to store medical accessories during steam sterilization to ensure that reproducible sterilization results are obtained.
Carl Zeiss Meditec AG
303060-0350-000
In Commercial Distribution

  • 04049539100610 ()


  • Surgical instrument/implant rack
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