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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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Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20143-2020P
Not in Commercial Distribution

  • 09421905067683 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20243-0815P
Not in Commercial Distribution

  • 09421905067676 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20243-1018P
Not in Commercial Distribution

  • 09421905067669 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20243-1122P
Not in Commercial Distribution

  • 09421905067652 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20153-0820G
Not in Commercial Distribution

  • 09421905067645 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20153-0416G
Not in Commercial Distribution

  • 09421905067638 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20353-2022G
Not in Commercial Distribution

  • 09421905067157 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R30353-1622G
Not in Commercial Distribution

  • 09421905067140 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY4030UA2
In Commercial Distribution

  • 04540778169791 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 2.8 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 4.0 mm
DC-PY4030UA2

  • Coronary angioplasty balloon catheter, basic
OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY3530UA2
In Commercial Distribution

  • 04540778169777 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.7 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 3.5 mm
DC-PY3530UA2

  • Coronary angioplasty balloon catheter, basic
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