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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
Absorbent Paper Points, 02 Taper 20, 200 Points, P 31R
Meta Biomed Co., Ltd.
2719
In Commercial Distribution

  • 08806387827191 ()


  • Endodontic paper point
No Description
W.H. Holden, Inc.
10-7320
In Commercial Distribution

  • D9281073200 ()


  • Instrument tray, reusable
No Description
QUINTRON INSTRUMENT COMPANY, INC.
QT00991-P
In Commercial Distribution

  • 00850010197852 ()
  • 00850010197050 ()
QT00991-P

  • Breath specimen container IVD
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
353
In Commercial Distribution

  • 00842430112737 ()
353

  • Traction weight
No Description
Joline GmbH & Co. KG
US9503
In Commercial Distribution

  • 04250203940894 ()


  • General-purpose syringe, single-use
No Description
SIZEWISE RENTALS, L.L.C.
DAC20
In Commercial Distribution

  • 00845699001309 ()


  • Commode, manual
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
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