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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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The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. 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 (RO, DI, etc.). Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it. CONTRAINDICATIONS Medical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used. Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
NEPHROS, INC.
W2T912244
In Commercial Distribution

  • 00896241002732 ()
  • 10896241002739 ()
  • 20896241002736 ()
70-0251M

  • Haemodialysis system dialysate pyrogen filter
Kit Contains: R138 Montana Jack® Scaler R061 Barnhart 5-6 R030 Amazing Gracey™ 15-16
PDT, INC.
R908 - PDT Demo Wallet 3 Pack - Hygiene
In Commercial Distribution

  • 00813677025210 ()
R908

  • Periodontal curette
  • Manual dental scaler, reusable
Kit Includes: R067 Columbia 4L-4R R138R Montana Jack® Rigid R120 Montana 4-5™ Scaler R030R Amazing Gracey™ 15-16 Rigid T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7 R028R Amazing Gracey™ 13-14 Rigid
PDT, INC.
R978 Gross Debridement Kit
In Commercial Distribution

  • 00813677024510 ()
R978

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
SCALER, DOUBLE END, TRADE IN, OFFSET SICKLE MONTANA JACK UNIVERSAL R138 THIN BLADE, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCNMJF
In Commercial Distribution

  • 00840018647466 ()


  • Manual dental scaler, reusable
No Description
W.H. Holden, Inc.
70-5164RK
In Commercial Distribution

  • D928705164RK0 ()


  • Periodontal curette
No Description
PDT, INC.
Montana 4-5 Scaler
In Commercial Distribution

  • 00813677020826 ()
R120

  • Manual dental scaler, reusable
Kit Includes: R144 Queen of Hearts™ R138BC Montana Jack® (Breast Cancer Pink) R120 Montana 4-5™ Scaler R044 Amazing Gracey™ 15-16 Extended Reach R043 Amazing Gracey™ 13-14 Extended Reach R093 N128-L5 Mini R067 Columbia 4L-4R T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7
PDT, INC.
R976 Perio Maintenance Kit
In Commercial Distribution

  • 00813677024442 ()
R976

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
Kit Includes: R144 Queen of Hearts™ R138BC Montana Jack® (Breast Cancer Pink) R120 Montana 4-5™ Scaler R044 Amazing Gracey™ 15-16 Extended Reach R043 Amazing Gracey™ 13-14 Extended Reach R093 N128-L5 Mini R067 Columbia 4L-4R T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7
PDT, INC.
R975 SRP Kit
In Commercial Distribution

  • 00813677024435 ()
R975

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
Kit Includes: T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 R028 Amazing Gracey™ 13-14 R030 Amazing Gracey™ 15-16 R061 Barnhart 5-6 R135 204S R138 Montana Jack®
PDT, INC.
R974 Adult Prophy Kit
In Commercial Distribution

  • 00813677024428 ()
R974

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
Kit Includes: T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 R096 N1 R139 N2 R138BC Montana Jack® (Breast Cancer Pink) R064 Columbia 13-14 R130S Jack B. Nimble® Slim Scaler
PDT, INC.
R977 Gingival Inflammation Kit
In Commercial Distribution

  • 00813677024527 ()
R977

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
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