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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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TUTEM - 00817583020406

EARLOOP, TUTEM- KEEP IT TO YOURSELF.
Alpha Pro Tech, Inc.
6055-6 KEEP IT TO YOURSELF
Not in Commercial Distribution

  • 10817583020403 ()
  • 00817583020406 ()
6055-6 KEEP IT TO YOURSELF

  • Surgical hood

Tatum Surgical Custom Abutment (Post) - 00083208700002

Implant Abutment neck diameter ( 3.5 to 5.0mm), 9mm height, between 40° and 60° as required - prescribed for patient by Dentist
Suncoast Dental, Inc
Custom Abutment
Not in Commercial Distribution

  • 00083208700002 ()

  • Height: 9 Millimeter
  • Custom Implant Abutment Angle between 40° and 60°
Custom PN 40° to 60°

  • Screw endosteal dental implant, two-piece

Norav 1200 Series PC-ECG - 07290110252717

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 Ana to 301
In Commercial Distribution

  • 07290110252717 ()
SW NH300 Ana to 301

  • Electrocardiographic long-term ambulatory recording analyser

Persona Medical - 00851362008124

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XS
In Commercial Distribution

  • 00851362008124 ()


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

Persona Medical - 00851362008117

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VS
In Commercial Distribution

  • 00851362008117 ()


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

Persona Medical - 00851362008100

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XR
In Commercial Distribution

  • 00851362008100 ()


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

Persona Medical - 00851362008094

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VR
In Commercial Distribution

  • 00851362008094 ()


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

Orantech - 06941691969327

Replacement Disposable Sidestream ETCO2 Capnotrak Airway Adapter Set 4.0mm For Adult Respironics 1103414 Philips 989803198991
Orantech Inc.
TNC-RP-AA001
In Commercial Distribution

  • 06941691969327 ()


  • Anaesthesia workstation common gas outlet

Slide.fit - 04048817590150

donning aid for transfemoral prostheses, size XXL, dark grey / orange
Streifeneder ortho.production GmbH
17A1/XXL
In Commercial Distribution

  • 04048817590150 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/XXL

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590143

donning aid for transfemoral prostheses, size XL, dark grey / light blue
Streifeneder ortho.production GmbH
17A1/XL
In Commercial Distribution

  • 04048817590143 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/XL

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590136

donning aid for transfemoral prostheses, size L, dark grey / green
Streifeneder ortho.production GmbH
17A1/L
In Commercial Distribution

  • 04048817590136 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/L

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590129

donning aid for transfemoral prostheses, size M, dark grey / dark blue
Streifeneder ortho.production GmbH
17A1/M
In Commercial Distribution

  • 04048817590129 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/M

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590112

donning aid for transfemoral prostheses, size S, dark grey / red
Streifeneder ortho.production GmbH
17A1/S
In Commercial Distribution

  • 04048817590112 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/S

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590105

donning aid for transfemoral prostheses, size XS, dark grey / yellow
Streifeneder ortho.production GmbH
17A1/XS
In Commercial Distribution

  • 04048817590105 ()

  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
17A1/XS

  • Mechanical-resistance external knee prosthesis

MEDI - 00636257156186

TG 8MM 3# FOAM CONDYLAR BK/BK HOOK
MEDI MANUFACTURING, INC.
201561
In Commercial Distribution

  • 00636257156186 ()


  • Knee support orthosis

TITAN IMPLANTS, INC. - 00842448112347

Titan Design 4.8mm Tg Hex Abutment Analog Aluminum
TITAN IMPLANT INC
TN-48TGHAA-AL
In Commercial Distribution

  • 00842448112347 ()


  • Dental implant abutment analog, laboratory

XiVE® - EFRI322593012

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259301
Not in Commercial Distribution

  • EFRI322593012 ()
25-9301

  • Dental implant suprastructure kit

XiVE® - EFRI322596002

XiVE® TG Lab Set Gold Bar Coping
Dentsply Implants Manufacturing GmbH
32259600
Not in Commercial Distribution

  • EFRI322596002 ()
25-9600

  • Dental implant suprastructure kit

XiVE® - EFRI322593002

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259300
Not in Commercial Distribution

  • EFRI322593002 ()
25-9300

  • Dental implant suprastructure kit

XiVE® - EFRI322541062

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

  • EFRI322541062 ()
25-4106

  • Dental implant suprastructure kit
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