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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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No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode
No Description
Biomet Orthopedics, LLC
10485
In Commercial Distribution

  • 00887868001543 ()
10485

  • External orthopaedic fixation system, single-use
RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit.
SAIMA GLOBAL FARMA S.L.
Gel 1 mL Syringe
In Commercial Distribution

  • 08437027710087 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
No Description
ALIMED, INC.
72124
In Commercial Distribution

  • 00733657228069 ()
2970009612

  • Patient transfer/turning sheet, single-use
3.2mm Drill with Stop
TOTAL JOINT ORTHOPEDICS, INC.
2009.00.000
In Commercial Distribution

  • 00819251027441 ()


  • Fluted surgical drill bit, reusable
A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
31161
In Commercial Distribution

  • M4853116128 ()
  • M4853116117 ()


  • Heat/moisture exchanger/microbial medical gas filter
Epstein Abdominoplasty Retractor, 240x27mm blade with 60mm wide working end with teeth, with ergonomic handle,with Fiberoptic, with Suction
ELMED INCORPORATED
37322-26FS
In Commercial Distribution

  • 00198506083181 ()
37322-26FS

  • Hand-held surgical retractor, reusable
  • Fibreoptic retractor handle
The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
BSB-0358-50
In Commercial Distribution

  • B502BSB0358500 ()

  • Total Volume: 50 Milliliter
BSB-0358-50

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
BSB-0358-15
In Commercial Distribution

  • B502BSB0358150 ()

  • Total Volume: 15 Milliliter
BSB-0358-15

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
BSB-0358-100
In Commercial Distribution

  • B502BSB03581000 ()

  • Total Volume: 100 Milliliter
BSB-0358-100

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
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