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No Description
CAPSTONE SURGICAL TECHNOLOGIES
S0004
Not in Commercial Distribution
- 10862106000301 ()
- 20862106000308 ()
- Surgical irrigation/aspiration handpiece, single-use
Ultraviolet Light system
LUMA THERAPEUTICS, INC.
CAT0582
In Commercial Distribution
- 10860228002104 ()
- Light-energy skin surface treatment system applicator
Kidney Stone Transportation Kit
Ditek Consulting, LLC
71340
In Commercial Distribution
- 10860009616032 ()
- General specimen receptacle transport container
The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
Lineage Biomedical, Inc.
NBK20
In Commercial Distribution
- 10860009080505 ()
NBK20
- General-purpose syringe/needle
The ASP VIAL is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404.
The ASP VIAL is used to homogenize and dispense the buffer and patient sample into the Sample Pod prior to loading into the device for deposition on to the slide.
ASP Health Inc.
A-03
In Commercial Distribution
- 20860008222439 ()
- 10860008222432 ()
PI-0085469
- Microscope slide stainer IVD
The ASP HOOD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404.
The ASP HOOD protects the user from exposure to potentially hazardous material and prevents possible sample cross contamination by sealing and containing the staining reagents and sample during device operation.
ASP Health Inc.
A-03
In Commercial Distribution
- 10860008222425 ()
- 20860008222422 ()
PI-0077054
- Microscope slide stainer IVD
The ASP POD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404.
The ASP POD is used to hold the sample that is to be deposited onto the slide.
ASP Health Inc.
A-03
In Commercial Distribution
- 20860008222415 ()
- 10860008222418 ()
PI-0077055
- Microscope slide stainer IVD
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0810
In Commercial Distribution
- 10860008106572 ()
FDSD0810
- Collagen wound matrix dressing
VR Thumb Loop Gown, Regular 4 Mil Green, Case - 50 Ct.
POLYCONVERSIONS, INC.
42406
In Commercial Distribution
- 10860006079175 ()
- Surgical/examination garment kit
Sleeve Gloves 15 Mil Extra Small Green Unlined - Case 100 Ct.
POLYCONVERSIONS, INC.
41260
In Commercial Distribution
- 10860006079144 ()
- Surgical/examination garment kit