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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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Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0120
Not in Commercial Distribution

  • 20866318000378 ()
  • 00866318000374 ()
  • 10866318000371 ()


  • Microbial water purification filter, non-sterilizable
to be used to attach Impression copings to abutments and Abutment replicas when making an impression of the implant site and a cast for the prosthesis
Cochlear Bone Anchored Solutions AB
90796
In Commercial Distribution

  • 09321502063388 ()


  • General external orthopaedic fixation system implantation kit, reusable
Laboratory component for prior generation Vistafix
Cochlear Bone Anchored Solutions AB
90796
In Commercial Distribution

  • 09321502016018 ()

  • 20 mm long guide pin
  • Length: 20 Millimeter
90796

  • General external orthopaedic fixation system implantation kit, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9460
In Commercial Distribution

  • 09348215026233 ()


  • Non-constrained polyethylene acetabular liner
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9456
In Commercial Distribution

  • 09348215026226 ()


  • Non-constrained polyethylene acetabular liner
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9660
In Commercial Distribution

  • 09348215026219 ()


  • Non-constrained polyethylene acetabular liner
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9656
In Commercial Distribution

  • 09348215026202 ()


  • Non-constrained polyethylene acetabular liner
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9652
In Commercial Distribution

  • 09348215026196 ()


  • Non-constrained polyethylene acetabular liner
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9260
In Commercial Distribution

  • 09348215026189 ()


  • Non-constrained polyethylene acetabular liner
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9256
In Commercial Distribution

  • 09348215026172 ()


  • Non-constrained polyethylene acetabular liner
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