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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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Dialysate Sack (SAK) with Concentrate - M535SAK302A0

No Description
NXSTAGE MEDICAL, INC.
SAK-302-A
In Commercial Distribution

  • M535SAK302A5 ()
  • M535SAK302A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3020

No Description
NXSTAGE MEDICAL, INC.
SAK-302
In Commercial Distribution

  • M535SAK3025 ()
  • M535SAK3020 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK301A0

No Description
NXSTAGE MEDICAL, INC.
SAK-301-A
In Commercial Distribution

  • M535SAK301A5 ()
  • M535SAK301A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3010

No Description
NXSTAGE MEDICAL, INC.
SAK-301
In Commercial Distribution

  • M535SAK3015 ()
  • M535SAK3010 ()


  • Haemodialysis concentrate

NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP - M535CAR5350

No Description
NXSTAGE MEDICAL, INC.
CAR-535
In Commercial Distribution

  • M535CAR5355 ()
  • M535CAR5350 ()


  • Haemodialysis/haemofiltration system component set

LIGHT BOND SEALANT WITH FLOURIDE - D82813302100

No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
1330210
In Commercial Distribution

  • D82813302100 ()


  • Orthodontic bracket adhesive

Sonigel Lotion with Aloe Vera - 10816864020323

Sonigel 1864 (4 x 1 gallon)
METTLER ELECTRONICS CORP.
1864
In Commercial Distribution

  • 10816864020323 ()
1864

  • Transcutaneous electrical stimulation electrode, single-use

Bipolar Instrument Handle with Lock - 10815288013898

No Description
ENCISION, INC.
BP7200L
In Commercial Distribution

  • 10815288013898 ()
BP7200L

  • Electrosurgical handpiece, reusable

CORFLO PEG Kit with snare - 10815149025350

PEG Safety Kit Push Technique
CORPAK MEDSYSTEMS, INC.
30-4320-S7
In Commercial Distribution

  • 20815149025357 ()
  • 10815149025350 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4320-S7

  • Ultraviolet phototherapy unit, professional

CORFLO PEG Kit with snare - 10815149025343

PEG Kit Push Technique; with snare
CORPAK MEDSYSTEMS, INC.
30-4020-S7
In Commercial Distribution

  • 20815149025340 ()
  • 10815149025343 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4020-S7

  • Ultraviolet phototherapy unit, professional
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