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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BAROguard Sterile Components - Trachea Connector Pouch
Paragonix Technologies Inc
PRGNX-7007-003-002
In Commercial Distribution

  • 00850005470212 ()


  • General-purpose donor-organ preservation/transport system
BAROguard Sterile Components - Organ Container Bag Pouch
Paragonix Technologies Inc
PRGNX-7007-003-001
In Commercial Distribution

  • 00850005470205 ()


  • General-purpose donor-organ preservation/transport system
BAROguard Sterile Components - Zip Tie Gun Pouch
Paragonix Technologies Inc
PRGNX-7007-003-003
In Commercial Distribution

  • 00850005470199 ()


  • General-purpose donor-organ preservation/transport system
Paragonix LUNGguard SherpaCool (Inner Box)
Paragonix Technologies Inc
PRGNX-5005-002
In Commercial Distribution

  • 10850005470189 ()
  • 00850005470182 ()


  • General-purpose donor-organ preservation/transport system
Paragonix LUNGguard Shipper Base
Paragonix Technologies Inc
PRGNX-5005-001
In Commercial Distribution

  • 00850005470144 ()
  • 00850005470151 ()
  • 20850005470148 ()


  • General-purpose donor-organ preservation/transport system
BAROguard SherpaCool
Paragonix Technologies Inc
PRGNX-7007-002
In Commercial Distribution

  • 00850005470069 ()


  • General-purpose donor-organ preservation/transport system
PancreasPak Canister (Pouch)
Paragonix Technologies Inc
SHRP-3003
In Commercial Distribution

  • 10850005470059 ()
  • 00850005470052 ()


  • General-purpose donor-organ preservation/transport system
PancreasPak SherpaCool
Paragonix Technologies Inc
SHRP-3003-002
In Commercial Distribution

  • 00850005470618 ()
  • 00850005470045 ()


  • General-purpose donor-organ preservation/transport system
PancreasPak Shipper Base
Paragonix Technologies Inc
SHRP-3003-001
In Commercial Distribution

  • 10850005470035 ()
  • 00850005470038 ()


  • General-purpose donor-organ preservation/transport system
LIVERguard SherpaCool
Paragonix Technologies Inc
PRGNX-6006-002
In Commercial Distribution

  • 20850005470292 ()
  • 10850005470295 ()


  • General-purpose donor-organ preservation/transport system
SherapaPak SherpaCool Ribbons and Pouch
Paragonix Technologies Inc
SHRP-1001-002
In Commercial Distribution

  • 10850005470271 ()
  • 20850005470278 ()


  • General-purpose donor-organ preservation/transport system
BAROguard SherpaCool Outer Box Contains: BAROguard SherpaCool Inner Box (00850005470229)
Paragonix Technologies Inc
112
Not in Commercial Distribution

  • 10850005470226 ()
PRGNX-7007-002

  • General-purpose donor-organ preservation/transport system
No Description
AVID MEDICAL, INC.
GHOP014-12_0003
In Commercial Distribution

  • 10809160209769 ()
GHOP014-12

  • General-purpose donor-organ preservation/transport system
No Description
AVID MEDICAL, INC.
LABM035-12AUX3_0002
In Commercial Distribution

  • 20809160210182 ()
  • 10809160210185 ()
LABM035-12AUX3

  • General-purpose donor-organ preservation/transport system
LifePort® Kidney Transporter 1.0
ORGAN RECOVERY SYSTEMS, INC.
LKT100P
In Commercial Distribution

  • 00815045020001 ()


  • General-purpose donor-organ preservation/transport system
Lung Preservation System
Traferox Technologies Inc
909-0011
In Commercial Distribution

  • 07540161670153 ()


  • General-purpose donor-organ preservation/transport system
LifePort® Kidney Transporter 1.1
ORGAN RECOVERY SYSTEMS, INC.
LKT101P
In Commercial Distribution

  • 00815045020018 ()


  • General-purpose donor-organ preservation/transport system
The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
104-000
Not in Commercial Distribution

  • 00860296000142 ()


  • Dermatological laser beam guiding handpiece
System for skin surface treatment by fractional Laser.
Ellipse A/S
Ydun
In Commercial Distribution

9SYS7852

  • Dermatological laser beam guiding handpiece
TIP, SM EXT ROLLER, FRAXEL, DOM
SOLTA MEDICAL
MC-F2-RT1ES
In Commercial Distribution

  • 00850608002711 ()
MC-F2-RT1ES

  • Dermatological laser beam guiding handpiece
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