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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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Analog Ø 4,3
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566616013 ()
IPD/JA-AW-00

  • Dental implant analog
Digital analog Ø 3,8
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566616006 ()
IPD/JA-AR-00/3D

  • Dental implant analog
Analog Ø 3,8
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566615993 ()
IPD/JA-AR-00

  • Dental implant analog
Digital analog Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566615986 ()
IPD/JA-AN-00/3D

  • Dental implant analog
No Description
FLOTEC INC
RW Regulator
In Commercial Distribution

  • B741RW0 ()


  • Non-fixed medical gas cylinder regulator
No Description
FLOTEC INC
Mass Casualty Assembly
In Commercial Distribution

  • B741MC0 ()


  • High-pressure medical gas hose
  • Medical gas flowmeter, dial-type
  • Non-fixed medical gas cylinder regulator
No Description
FLOTEC INC
Flowmeter
In Commercial Distribution

  • B741FM0 ()


  • Medical gas flowmeter, dial-type
No Description
FLOTEC INC
InGage Regulator
In Commercial Distribution

  • B741DL0 ()


  • Non-fixed medical gas cylinder regulator
The G5 Vibracare ZX1 Percussor is our durable, hand-held percussor used in respiratory therapy applications. Totally self-contained, and weighing less than three pounds, it provides optimal freedom of movement and portability with a ten foot hospital grade power cord. This model may be used with a variety of applicators and has a continuously-variable speed range of 20 - 50 cycles per second. This combination of applicators and speeds provides for a highly-versatile treatment range. It is the only hand-held percussor/massager to be granted C.S.A's highest medical operational rating. Comes with applicators 212, 216, 229, 230.
GENERAL PHYSIOTHERAPY INC
VIBRACARE ZX1
In Commercial Distribution

  • 00007469820231 ()

  • Weight: 6 Pound
VIBRACARE ZX1

  • Hand-held electric massager
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
EVAL-AS-25
In Commercial Distribution

  • 00850054813312 ()
  • 10850054813319 ()
EVAL-AS-25

  • General-purpose medical fibre padding
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
EVAL-AM-25
In Commercial Distribution

  • 00850054813305 ()
  • 10850054813302 ()
EVAL-AM-25

  • General-purpose medical fibre padding
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
EVAL-AL-25
In Commercial Distribution

  • 00850054813299 ()
  • 10850054813296 ()
EVAL-AL-25

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
SMPL-AL-100
In Commercial Distribution

  • 00850054813282 ()
  • 10850054813289 ()


  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
In Commercial Distribution

  • 00850054813244 ()
  • 10850054813241 ()


  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
In Commercial Distribution

  • 00850054813206 ()
  • 10850054813203 ()


  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
SMPL-AL-100
Not in Commercial Distribution

  • 00850054813114 ()
  • 10850054813111 ()
SMPL-AL-100

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
Not in Commercial Distribution

  • 00850054813107 ()
  • 10850054813104 ()
SMPL-AM-100

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
Not in Commercial Distribution

  • 00850054813091 ()
  • 10850054813098 ()
SMPL-AS-100

  • General-purpose medical fibre padding
Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent
Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent
No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
KANG ZE INDUSTRIAL CO., LTD
9225
In Commercial Distribution

  • 06972543480127 ()
  • 06972543480097 ()


  • Electronic thermometer probe cover
The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
KANG ZE INDUSTRIAL CO., LTD
9028
In Commercial Distribution

  • 06972543480110 ()
  • 06972543480080 ()


  • Electronic thermometer probe cover
The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
KANG ZE INDUSTRIAL CO., LTD
12028
In Commercial Distribution

  • 06972543480103 ()
  • 06972543480073 ()


  • Electronic thermometer probe cover
EMST150 expiratory muscle strength trainer (handheld exerciser ).The EMST150 is a calibrated muscle strength trainer designed specifically for individuals who want to increase the strength of their voice,cough and swallow muscles
Aspire Products LLC
150
In Commercial Distribution

  • 00793573085498 ()


  • PEEP valve, reusable
No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M607
In Commercial Distribution

  • 06977160620055 ()


  • Air-conduction hearing aid, in-the-ear
No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M609
In Commercial Distribution

  • 06977160620048 ()


  • Air-conduction hearing aid, in-the-ear
No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M908
In Commercial Distribution

  • 06977160620031 ()


  • Air-conduction hearing aid, behind-the-ear
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