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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Attachment Head B2
IPG Medical Corporation
MD2300F-002247
In Commercial Distribution

  • 00810071230585 ()


  • Musculoskeletal/physical therapy laser, professional
Attachment Head C
IPG Medical Corporation
MD2300F-002246
In Commercial Distribution

  • 00810071230578 ()


  • Musculoskeletal/physical therapy laser, professional
Attachment Head B1
IPG Medical Corporation
MD2300F-002244
In Commercial Distribution

  • 00810071230554 ()


  • Musculoskeletal/physical therapy laser, professional
Universal Stage One Handpiece
IPG Medical Corporation
MD2300F-001754
In Commercial Distribution

  • 00810071230547 ()


  • Musculoskeletal/physical therapy laser, professional
Attachment Head D
IPG Medical Corporation
MD2300F-002245
In Commercial Distribution

  • 00810071230592 ()


  • Musculoskeletal/physical therapy laser, professional
Two Port Controller for Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-C2J
In Commercial Distribution

  • 00858935006679 ()
502054

  • Musculoskeletal infrared phototherapy unit, non-wearable
Two Port 'In-line' Controller, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-C2
In Commercial Distribution

  • 00858935006594 ()
502045

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Blue/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132B
In Commercial Distribution

  • 00858935006518 ()
602024

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Blue/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264B
In Commercial Distribution

  • 00858935006488 ()
602021

  • Musculoskeletal infrared phototherapy unit, non-wearable
64-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-64R
In Commercial Distribution

  • 00858935006457 ()
602018

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264R
In Commercial Distribution

  • 00858935006419 ()
602014

  • Musculoskeletal infrared phototherapy unit, non-wearable
180-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-180R
In Commercial Distribution

  • 00858935006402 ()
602013

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132R
In Commercial Distribution

  • 00858935006396 ()
602012

  • Musculoskeletal infrared phototherapy unit, non-wearable
90-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-90R
In Commercial Distribution

  • 00858935006389 ()
602011

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Calf Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-NP
In Commercial Distribution

  • 00858935006266 ()
502032

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Ankle Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-PB
In Commercial Distribution

  • 00858935006068 ()
502006

  • Musculoskeletal infrared phototherapy unit, non-wearable
FallGuard CordLess monitor with Infra-Red Motion Sensor
Smart Caregiver Corporation
GPIR1-SYS
In Commercial Distribution

  • 00812293011690 ()


  • Nurse call system alarm
PILLOW SPEAKER, ELITE INFRARED, WESTCOM, 12 PIN,
Crest Healthcare Supply
XTWCCCEIXXXXTAAYL
In Commercial Distribution

  • B484XTWCCCEIXXXXTAAYL0 ()

  • Length: 8 Feet
  • Length: 10 Feet


  • Nurse call system
A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin.
SenTec AG
PAK-SF
Not in Commercial Distribution

  • 17640121880978 ()
  • 07640121880971 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin
SenTec AG
PAK-MI
Not in Commercial Distribution

  • 17640121880961 ()
  • 07640121880964 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
This clear, amorphous antimicrobial wound gel is designed to provide a moist healing environment and to help control bioburden.
CP Skin Health Group, Inc.
02530
Not in Commercial Distribution

  • 00390205025305 ()
  • 10090205025301 ()


  • Wound hydrogel dressing, antimicrobial
This clear, amorphous antimicrobial wound gel is designed to provide a moist healing environment and to help control bioburden.
CP Skin Health Group, Inc.
02528
Not in Commercial Distribution

  • 10090205025288 ()
  • 00390205025282 ()


  • Wound hydrogel dressing, antimicrobial
No Description
CP Skin Health Group, Inc.
02526
Not in Commercial Distribution

  • 10090205025264 ()
  • 00390205025268 ()


  • Wound hydrogel dressing, antimicrobial
EltaMD® Dermal Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.
CP Skin Health Group, Inc.
02531
In Commercial Distribution

  • 00090205025311 ()
  • 10090205025318 ()


  • Skin detergent
EltaMD Laser Enzyme Gel: is an enzyme-enhanced moisturizer that promotes skin recovery, moisturization, and comfort when used after non-ablative and mildly ablative procedures.
CP Skin Health Group, Inc.
02267
Not in Commercial Distribution

  • 10090205022676 ()
  • 00090205022679 ()


  • Wound hydrogel dressing, non-antimicrobial
No Description
CP Skin Health Group, Inc.
03900
In Commercial Distribution

  • 00827854009832 ()
  • 10827854009839 ()


  • Wound hydrogel dressing, antimicrobial
No Description
CP Skin Health Group, Inc.
04000
In Commercial Distribution

  • 00827854001119 ()
  • 10827854001116 ()


  • Wound hydrogel dressing, non-antimicrobial
No Description
Biomet Orthopedics, LLC
110031178
In Commercial Distribution

  • 00880304818965 ()

  • Patient Matched
110031178

  • Custom-made organ/bone anatomy model/surgical guide kit
No Description
Biomet Orthopedics, LLC
110019066
In Commercial Distribution

  • 00880304818958 ()

  • Patient Matched
110019066

  • Custom-made organ/bone anatomy model/surgical guide kit
No Description
Biomet Orthopedics, LLC
110027735
In Commercial Distribution

  • 00880304818941 ()

  • PATIENT MATCHED
110027735

  • Reverse shoulder prosthesis base plate
No Description
Biomet Orthopedics, LLC
110027734
In Commercial Distribution

  • 00880304818934 ()

  • PATIENT MATCHED
110027734

  • Reverse shoulder prosthesis base plate
N/A
Conformis, Inc.
HCC032000001
Not in Commercial Distribution

  • M572HCC0320000011 ()

  • Patient Specific
HCC0320000

  • Metallic acetabulum prosthesis
N/A
Conformis, Inc.
BKA111111101
Not in Commercial Distribution

  • M572BKA1111111011 ()

  • Patient Specific
BKA1111111

  • Bicompartmental knee prosthesis
HIP-PATIENT SPECIFIC STEM LEFT
Conformis, Inc.
HBS033000001
In Commercial Distribution

  • M572HBS0330000011 ()

  • Patient Specific
HBS0330000

  • Uncoated femoral stem prosthesis, one-piece
N/A
Conformis, Inc.
HAA050D00101
Not in Commercial Distribution

  • M572HAA050D001011 ()

  • Patient Specific
HAA050D001

  • Joint prosthesis implantation kit, single-use
N/A
Conformis, Inc.
UKA111111101
Not in Commercial Distribution

  • M572UKA1111111011 ()

  • Patient Specific
UKA1111111

  • Unicondylar knee prosthesis
ITOTAL PS–IPOLY XE–IMPLANT KIT–LEFT or right
Conformis, Inc.
TPS121111102
In Commercial Distribution

  • M572TPS1211111021 ()

  • Patient Specific
TPS1211111

  • Total knee prosthesis implantation guide-instrument kit
  • Posterior-stabilized total knee prosthesis
iTotal® Posterior Stabilized (PS) Knee Replacement System
Conformis, Inc.
TPS111111102
In Commercial Distribution

  • M572TPS1111111021 ()

  • Patient Specific
TPS1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Posterior-stabilized total knee prosthesis
ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED), RIGHT or left
Conformis, Inc.
TPS-101-111211
In Commercial Distribution

  • M572TPS1011112111 ()

  • Patient specific
TPS-101-1112

  • Uncoated knee femur prosthesis, metallic
PS JIGS, LEFT AND RIGHT
Conformis, Inc.
TPS000D00201
In Commercial Distribution

  • M572TPS000D002011 ()

  • Patient Specific
TPS-000-D002

  • Total knee prosthesis implantation guide-instrument kit
ITOTAL CR-IPOLY XE-IMPLANT KIT HYBRID-LEFT or right
Conformis, Inc.
TCR121SPEC02
In Commercial Distribution

  • M572TCR121SPEC021 ()

  • Patient Specific
TCR121SPEC

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR121111102
In Commercial Distribution

  • M572TCR1211111021 ()

  • Patient Specific
TCR1211111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
ITOTAL CR ? IPOLY XE ? IMPLANT KIT UNCAPTURED - LEFT or right
Conformis, Inc.
TCR121111101
In Commercial Distribution

  • M572TCR1211111011 ()

  • Patient Specific
TCR1211111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR111SPEC02
In Commercial Distribution

  • M572TCR111SPEC021 ()

  • Patient Specific
TCR111SPEC

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR111111102
In Commercial Distribution

  • M572TCR1111111021 ()

  • Patient Specific
TCR1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR111111101
In Commercial Distribution

  • M572TCR1111111011 ()

  • Patient Specific
TCR1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
ITOTAL IDENTITY CR FEMORAL IMPLANT (COCR, CEMENTED), LEFT or right
Conformis, Inc.
TCR-101-111211
In Commercial Distribution

  • M572TCR1011112111 ()

  • patient specific
TCR-101-1112

  • Uncoated knee femur prosthesis, metallic
N/A
Conformis, Inc.
RCR101111303
In Commercial Distribution

  • M572RCR1011113031 ()

  • Patient Specific
RCR1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RCR101111302
Not in Commercial Distribution

  • M572RCR1011113021 ()

  • Patient Specific
RCR1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RCR101111301
In Commercial Distribution

  • M572RCR1011113011 ()

  • Patient Specific
RCR1011113

  • Uncoated knee tibia prosthesis, metallic
  • Total knee prosthesis implantation guide-instrument kit
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