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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DIGITAL PROBE COVERS ORAL
D-M-S HOLDINGS, INC.
15-619-000
Not in Commercial Distribution

  • 10767056156194 ()
  • 00767056156197 ()
15-619-000

  • Electronic thermometer probe cover
DIGITAL PROBE COVERS ORAL
D-M-S HOLDINGS, INC.
15-618-000
In Commercial Distribution

  • 10767056156187 ()
  • 00767056156180 ()
15-618-000

  • Electronic thermometer probe cover
DIGITAL PROBE COVERS ORAL
D-M-S HOLDINGS, INC.
15-617-000
In Commercial Distribution

  • 10767056156170 ()
  • 00767056156173 ()
15-617-000

  • Electronic thermometer probe cover
DIGITAL PROBE COVERS ORAL
D-M-S HOLDINGS, INC.
15-615-000
Not in Commercial Distribution

  • 10767056156156 ()
  • 00767056156159 ()
15-615-000

  • Electronic thermometer probe cover
Tympanic Probe Covers
Covidien LP
8884810055
In Commercial Distribution

  • 20884521000367 ()
  • 10884521000360 ()
  • 30884521000364 ()
8884810055

  • Electronic thermometer probe cover
Reusable Thermometer Probe/Spacelabs/Adult/Esophageal+Skin/077/3.0M/Pacific
Unimed Medical Supplies, Inc.
NCSP5204
In Commercial Distribution

  • 06945664857895 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/20K/Adult/Skin/6.3 mono plug/1.55M
Unimed Medical Supplies, Inc.
T20-155AS
In Commercial Distribution

  • 06945664856560 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/10K/Pediatric/Skin/6.3 mono plug/3.0M
Unimed Medical Supplies, Inc.
T10-PS
In Commercial Distribution

  • 06945664856553 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/Marquette/Adult/Skin/063/3.0M/Jaken Medical
Unimed Medical Supplies, Inc.
TH-2021700-AS-NB
In Commercial Distribution

  • 06945664857802 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/Air shield/Adult/Skin/159/1.5M/Pacific
Unimed Medical Supplies, Inc.
NCAS5101
In Commercial Distribution

  • 06945664857482 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/Marquette/Adult/Esophageal+Skin/063/3.0M/Pacific
Unimed Medical Supplies, Inc.
NCMQ5204
In Commercial Distribution

  • 06945664857406 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/Marquette/Adult/Skin/063/3.0M/DRE GROUP
Unimed Medical Supplies, Inc.
P05246
In Commercial Distribution

  • 06945664857345 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/20K/Pediatric/Skin/6.3 stereo plug/1.5M
Unimed Medical Supplies, Inc.
T20-15PS
In Commercial Distribution

  • 06945664857338 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/YSI400/Adult/Skin/6.3 mono plug/3.0M
Unimed Medical Supplies, Inc.
T2252S-AS
In Commercial Distribution

  • 06945664856744 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/YSI700/Pediatric/Skin/6.3 stereo plug/3.0M
Unimed Medical Supplies, Inc.
T700-PS
In Commercial Distribution

  • 06945664855433 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/YSI400/Pediatric/Skin/6.3 mono male/3.0M
Unimed Medical Supplies, Inc.
T2252-PS
In Commercial Distribution

  • 06945664855280 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/YSI400/Adult/Skin/6.3 mono male/3.0M
Unimed Medical Supplies, Inc.
T2252-AS
In Commercial Distribution

  • 06945664855051 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/10K/Adult/Skin/6.3 mono plug/3.0M
Unimed Medical Supplies, Inc.
T10-AS
In Commercial Distribution

  • 06945664855037 ()


  • General-purpose patient temperature probe, reusable
Reusable Thermometer Probe/YSI700/Adult/Skin/6.3 stereo plug/3.0M
Unimed Medical Supplies, Inc.
T700-AS
In Commercial Distribution

  • 06945664841139 ()


  • General-purpose patient temperature probe, reusable
OMNILUX MEDICAL REVIVE2 HEAD
LOTUS GLOBAL GROUP, INC, THE
EM1654
In Commercial Distribution

  • B434EM1654 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
OMNILUX MEDICAL PLUS HEAD
LOTUS GLOBAL GROUP, INC, THE
EM1387
In Commercial Distribution

  • B434EM1387 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
OMNILUX MEDICAL BLUE HEAD
LOTUS GLOBAL GROUP, INC, THE
EM1310
In Commercial Distribution

  • B434EM1310 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
OMNILUX MEDICAL BASE
LOTUS GLOBAL GROUP, INC, THE
EM1258S
In Commercial Distribution

  • B434EM1258S0 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension, relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red, and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean.
Therabody, Inc.
TheraFace PRO Black
In Commercial Distribution

  • 00810036056724 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension, relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red, and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean.
Therabody, Inc.
TheraFace PRO White
In Commercial Distribution

  • 00810036056687 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-812W
Not in Commercial Distribution

  • 06976415770187 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-812B
Not in Commercial Distribution

  • 06976415770170 ()


  • Transcutaneous electrical stimulation probe
  • Blue/red/infrared phototherapy lamp
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-810W
Not in Commercial Distribution

  • 06976415770163 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-810B
Not in Commercial Distribution

  • 06976415770156 ()


  • Transcutaneous electrical stimulation probe
  • Blue/red/infrared phototherapy lamp
Classic-Round Probe Periodontal Se Color Coded Fig 12
Surgical Direct, Inc.
SD90297300
In Commercial Distribution

  • B382SD902973000 ()
SD90297300

  • Phosphorescent/fibreoptic patient thermometer
A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to to measure a patient's body temperature. The device has a flexible tip and an LCD display. It is designed to take a temperature reading in approximately 5 seconds. This is a reusable device.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
KD-1760
In Commercial Distribution

  • 40050428250448 ()
  • 00050428250440 ()


  • Intermittent electronic patient thermometer
A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to measure a patient's body temperature. The device has a flexible oral tip. It is designed to take a temperature reading in approximately 60 seconds. This is a reusable device.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
KD-2780
In Commercial Distribution

  • 40050428027491 ()
  • 00050428027493 ()


  • Intermittent electronic patient thermometer
TheraPlus CHILDRENS CHARACTER THERMOMETER
FOURSTAR GROUP INC.
11012340K
In Commercial Distribution

  • 00049696739795 ()


  • Intermittent electronic patient thermometer
TheraPlus CHILDRENS CHARACTER THERMOMETER
FOURSTAR GROUP INC.
11012340K
In Commercial Distribution

  • 00049696739351 ()


  • Intermittent electronic patient thermometer
TheraPlus Digital thermometer
FOURSTAR GROUP INC.
11012340F
In Commercial Distribution

  • 00049696738132 ()


  • Intermittent electronic patient thermometer
Theraplus DIGITAL THERMOMETER
FOURSTAR GROUP INC.
1
In Commercial Distribution

  • 00049696731379 ()


  • Intermittent electronic patient thermometer
No Description
Caring Mill
MT710-FSA
In Commercial Distribution

  • 10810025922242 ()
  • 00810025922245 ()
  • 20810025922249 ()


  • Intermittent electronic patient thermometer
No Description
Caring Mill
MT700-FSA
In Commercial Distribution

  • 10810025922235 ()
  • 00810025922238 ()
  • 20810025922232 ()


  • Intermittent electronic patient thermometer
No Description
Caring Mill
MT19U1-FSA
In Commercial Distribution

  • 10810025922211 ()
  • 00810025922214 ()
  • 20810025922218 ()


  • Intermittent electronic patient thermometer
No Description
Caring Mill
MT3001-FSA
In Commercial Distribution

  • 10810025922204 ()
  • 00810025922207 ()
  • 20810025922201 ()


  • Intermittent electronic patient thermometer
Quick-Read Digital Thermometer
Caring Mill
DT-105-FSA
In Commercial Distribution

  • 00810025921170 ()
DT-105-FSA

  • Intermittent electronic patient thermometer
3-in-1- Nursery Thermometer
DOREL JUVENILE GROUP, INC.
TH108
In Commercial Distribution

  • 20884392945286 ()


  • Intermittent electronic patient thermometer
Touch Free Forehead Thermometer - Target
DOREL JUVENILE GROUP, INC.
TH106
In Commercial Distribution

  • 20884392945118 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
49543
In Commercial Distribution

  • 20884392940649 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
TH097
In Commercial Distribution

  • 20884392619965 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
TH096
In Commercial Distribution

  • 20884392618586 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
TH088
In Commercial Distribution

  • 20884392609263 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
TH084
In Commercial Distribution

  • 20884392608709 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
TH076
In Commercial Distribution

  • 20884392597591 ()


  • Intermittent electronic patient thermometer
No Description
DOREL JUVENILE GROUP, INC.
TH075
In Commercial Distribution

  • 20884392597584 ()


  • Intermittent electronic patient thermometer
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