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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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LINK Embrace Shoulder System - 04026575234707

Humeral Fracture Stems
WALDEMAR LINK GmbH & Co. KG
641-120/24
In Commercial Distribution

  • 04026575234707 ()
641-120/24

  • Uncoated shoulder humeral stem prosthesis

LINK Embrace Shoulder System - 04026575234356

Humeral Standard Stems
WALDEMAR LINK GmbH & Co. KG
640-100/24
In Commercial Distribution

  • 04026575234356 ()
640-100/24

  • Uncoated shoulder humeral stem prosthesis

allSoft - 00812261010069

allSoft Ureteral Stent Open Tip 5F, 24cm
ALLWIN MEDICAL DEVICES, INC.
allSoft Ureteral Stent Open Tip
In Commercial Distribution

  • 10812261010066 ()
  • 00812261010069 ()
SOT5/24

  • Polymeric ureteral stent

Malar Implant - B049SM240

Sterile, silicone, malar implant, pair.
Hanson Medical, Inc.
SM 2-4
In Commercial Distribution

  • B049SM240 ()
SM 2-4

  • Malar prosthesis

Chin Implant - B049SCH240

Sterile, silicone, chin implant.
Hanson Medical, Inc.
SCH 2-4
In Commercial Distribution

  • B049SCH240 ()
SCH 2-4

  • Chin prosthesis

Malar Implant - B049M240

Non-sterile, silicone, malar implant, pair.
Hanson Medical, Inc.
M 2-4
In Commercial Distribution

  • B049M240 ()
M 2-4

  • Malar prosthesis

Chin Implant - B049CH240

Non-sterile, silicone, chin implant.
Hanson Medical, Inc.
CH 2-4
In Commercial Distribution

  • B049CH240 ()
CH 2-4

  • Chin prosthesis

Calf Implant - B049CCB240

Non-sterile, silicone, calf implant.
Hanson Medical, Inc.
CCB 2-4
In Commercial Distribution

  • B049CCB240 ()
CCB 2-4

  • Silicone-block tissue reconstructive material

HEMO-FLOW® - 00884908140989

14.5F X 24CM HEMO-FLOW® DOUBLE LUMEN CATHETER SETDOUBLE (CUFF 19CM FROM TIP)(CUFF 19CM F
Medical Components, Inc.
DHFS 24
In Commercial Distribution

  • 50884908140984 ()
  • 00884908140989 ()
DHFS 24

  • Double-lumen haemodialysis catheter, implantable

HEMO-FLOW® - 00884908185010

14.5F X 24CM HEMO-FLOW® DOUBLE LUMEN CATHETER SET (CUFF 19CM FROM TIP)
Medical Components, Inc.
DHFS 24
In Commercial Distribution

  • 50884908185015 ()
  • 00884908185010 ()
DHFS 24

  • Double-lumen haemodialysis catheter, implantable
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