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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 - 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

Mojave Mobile with Amalgam Separator - E247ATH71002000

Mobile dental suction system
DÜRR DENTAL SE
ATH7100200
In Commercial Distribution

  • E247ATH71002000 ()


  • Dental suction system

Mojave Mobile with Amalgam Separator - E247ATH71001000

Mobile dental suction system
DÜRR DENTAL SE
ATH7100100
In Commercial Distribution

  • E247ATH71001000 ()


  • Dental suction system

PLEGIOX Heat Exchanger with Cardioplegia - 04037691180038

The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
CHX 30, Non-coated, Sterile
Not in Commercial Distribution

  • 04037691180038 ()
  • 04058863052267 ()

  • Total Volume: 46.885 Liter
  • Weight: 0.35 Kilogram
70103.2522

  • Cardiopulmonary bypass system heat exchanger, reusable

LOCATOR, compatible with Implant Direct - 00840481134098

LOCATOR Female Analog (4.0mm) (4 pack)
Zest Anchors, LLC
08530
In Commercial Distribution

  • 00840481134098 ()
08530-ID-SB

  • Dental implant analog

LOCATOR, compatible with Anthogyr System - 00840481127519

LOCATOR Female Analog (4.0mm) (4 Pack)
Zest Anchors, LLC
08530
In Commercial Distribution

  • 00840481127519 ()
08530-AN-SB

  • Dental implant analog

LOCATOR, compatible with Ankylos System - 00840481127298

LOCATOR Processing Spacer (4 Pack)
Zest Anchors, LLC
08569
In Commercial Distribution

  • 00840481127298 ()
08569-FD

  • Dental impression spacer

LOCATOR, compatible with Ankylos System - 00840481127243

LOCATOR Female Analog (5.0mm) (4Pack)
Zest Anchors, LLC
08516
In Commercial Distribution

  • 00840481127243 ()
08516-FD

  • Dental implant analog

LOCATOR, compatible with Ankylos System - 00840481127236

LOCATOR Female Analog (4.0mm)(4 Pack)
Zest Anchors, LLC
08530
In Commercial Distribution

  • 00840481127236 ()
08530-FD

  • Dental implant analog
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