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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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Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK.
Novian Health Inc.
USA/EU/UK: 110 mm
In Commercial Distribution

  • 00860008944801 ()
100011-02

  • General/multiple surgical laser system beam guide, single-use
CHG 100 TendoNova Ocelot Nano Charger
Tendonova Corporation
CHG-100
In Commercial Distribution

  • 00860008843524 ()


  • Soft-tissue ultrasonic surgical system handpiece, reusable
RDU 1000 TendoNova Ocelot Nano Reusable Drive Unit
Tendonova Corporation
RDU-1000
In Commercial Distribution

  • 00860008843517 ()


  • Soft-tissue ultrasonic surgical system handpiece, reusable
TendoNova Ocelot DU1F60L Disposable Unit- 60mm
Tendonova Corporation
DU1F60L
In Commercial Distribution

  • 10860008843507 ()
  • 00860008843500 ()

  • Length: 60 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The Lucid Diagnostics EsoCheck CCD Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.
Lucid Diagnostics Inc
230-05203
In Commercial Distribution

  • 00860008795557 ()
  • 00860008795564 ()


  • Cytology scraper, single-use
7F Introducer Set
Aligned Medical Solutions
INT0707NG
In Commercial Distribution

  • 10860008549782 ()
  • 00860008549785 ()
  • 20860008549789 ()
  • 30860008549786 ()
INT0707NG

  • General surgical procedure kit, non-medicated, single-use
No Description
M. J. Winston International, Ltd.
cslarge24
In Commercial Distribution

  • 00860008514059 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
The Uro-G Flexible Cystoscope System consists of a multi-use handle with an LCD screen and a single-use sterile cannula. The Uro-G Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
UROVIU CORP.
1520
In Commercial Distribution

  • 00860008483706 ()
1520

  • Flexible video cystoscope, single-use
Rapid chromatographic immunoassays for the qualitative detection of LH in urine, as an aid in detection of ovulation. This test is intended for over-the-counter use.
The Bird And Be Co Inc
LHUS
In Commercial Distribution

  • 00860008449016 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Retrieval catheter with peel away sheath
Onocor LLC
ONO12-100
In Commercial Distribution

  • 00860008180605 ()


  • Intravascular extraction catheter-snare
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