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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PancreasPak SherpaCool
Paragonix Technologies Inc
SHRP-3003-002
In Commercial Distribution

  • 00850005470618 ()
  • 00850005470045 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 18mm
Paragonix Technologies Inc
SHRP-1001-000-002
In Commercial Distribution

  • 00869582000361 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 10mm
Paragonix Technologies Inc
SHRP-1001-000-001
In Commercial Distribution

  • 00869582000354 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System Canister Ships with 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001
In Commercial Distribution

  • 00869582000347 ()
  • 00869582000309 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak CTS Shipper Base
Paragonix Technologies Inc
SHRP-1001-001
In Commercial Distribution

  • 10869582000313 ()
  • 00869582000316 ()
  • 20869582000310 ()
  • 00850005470267 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 32mm
Paragonix Technologies Inc
SHRP-1001-000-004
In Commercial Distribution

  • 00869582000385 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 25.4mm
Paragonix Technologies Inc
SHRP-1001-000-003
In Commercial Distribution

  • 00869582000378 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001-003
Not in Commercial Distribution

  • 00869582000330 ()


  • 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
No Description
AVID MEDICAL, INC.
GHOP014-12_0003
In Commercial Distribution

  • 10809160209769 ()
GHOP014-12

  • 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
LifePort® Kidney Transporter 1.1
ORGAN RECOVERY SYSTEMS, INC.
LKT101P
In Commercial Distribution

  • 00815045020018 ()


  • 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
The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ 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 USB C connector interface that provides battery charging. The NIRA PRO+ is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
174-000
In Commercial Distribution

  • 00850020752454 ()


  • Dermatological laser beam guiding handpiece
The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece 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 USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece
The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO 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 USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • 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
TIP, CLEAR+BRILLIANT, PERMEA
SOLTA MEDICAL
CB-TIP-SCP
In Commercial Distribution

  • 00850608002704 ()
CB-TIP-SCP

  • Dermatological laser beam guiding handpiece
TIP, CLEAR+BRILLIANT
SOLTA MEDICAL
CB-TIP-SC
In Commercial Distribution

  • 00850608002698 ()
CB-TIP-SC

  • Dermatological laser beam guiding handpiece
REFURBISHED CLEAR AND BRILLIANT HANDPIECE 1927
SOLTA MEDICAL
CB-HP-1927-R
In Commercial Distribution

  • 00850608002681 ()
CB-HP-1927-R

  • Dermatological laser beam guiding handpiece
REFURBISHED CLEAR AND BRILLIANT HANDPIECE 1440
SOLTA MEDICAL
CB-HP-1440-R
In Commercial Distribution

  • 00850608002674 ()
CB-HP-1440-R

  • Dermatological laser beam guiding handpiece
REFURBISHED CLEAR AND BRILLIANT CONSOLE
SOLTA MEDICAL
CB-CONSOLE-R
In Commercial Distribution

  • 00850608002667 ()
CB-CONSOLE-R

  • Dermatological laser beam guiding handpiece
CLEAR+ BRILLIANT 1440 HANDPIECE
SOLTA MEDICAL
CB-HP-1440
In Commercial Distribution

  • 00850608002650 ()
CB-HP-1440

  • Dermatological laser beam guiding handpiece
No Description
SOLTA MEDICAL
CB-CONSOLE
In Commercial Distribution

  • 00850608002643 ()
CB-CONSOLE

  • Dermatological laser beam guiding handpiece
CLEAR + BRILLIANT 1927 HANDPIECE
SOLTA MEDICAL
CB-HP-1927
In Commercial Distribution

  • 00850608002636 ()
CB-HP-1927

  • 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
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
Pearl Fractional Standoffs
CUTERA, INC.
Pearl Fractional Standoffs
In Commercial Distribution

  • 00816722023100 ()
  • 00816722023101 ()


  • Dermatological laser beam guiding handpiece
Titan S IPL Handpiece
CUTERA, INC.
Titan S
In Commercial Distribution

  • 00816722022929 ()


  • Dermatological laser beam guiding handpiece
Titan V IPL Handpiece
CUTERA, INC.
Titan V
In Commercial Distribution

  • 00816722022905 ()


  • Dermatological laser beam guiding handpiece
Pearl Fractional Laser Handpiece for xeo+/xeo+ SA
CUTERA, INC.
Pearl Fractional
In Commercial Distribution

  • 00816722022844 ()


  • Dermatological laser beam guiding handpiece
OPS600 IPL Handpiece
CUTERA, INC.
OPS600
In Commercial Distribution

  • 00816722022172 ()


  • Dermatological laser beam guiding handpiece
LP560 IPL Handpiece
CUTERA, INC.
LP560
In Commercial Distribution

  • 00816722022165 ()


  • Dermatological laser beam guiding handpiece
Pearl Fractional Laser Handpiece
CUTERA, INC.
Pearl Fractional
In Commercial Distribution

  • 00816722022158 ()


  • Dermatological laser beam guiding handpiece
Pearl Laser Handpiece
CUTERA, INC.
Pearl
In Commercial Distribution

  • 00816722022141 ()


  • Dermatological laser beam guiding handpiece
ProWave LX IPL Handpiece
CUTERA, INC.
ProWave 770
In Commercial Distribution

  • 00816722022127 ()


  • Dermatological laser beam guiding handpiece
Twain 2940 for Quantaforte
QUANTA SYSTEM SPA
OAM001656
In Commercial Distribution

  • 08033945938406 ()


  • Dermatological laser beam guiding handpiece
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