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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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Tube with cap, 57x16.5mm - 04038917111362

No Description
Sarstedt Aktiengesellschaft & Co.KG
62.542.055
In Commercial Distribution

  • 04038917187916 ()
  • 04038917111362 ()
62.542.055

  • Assay container IVD, single-use

Cap with volume limitation - 04038917083607

No Description
Sarstedt Aktiengesellschaft & Co.KG
65.710
In Commercial Distribution

  • 04038917165822 ()
  • 04038917083607 ()
65.710

  • Test tube/reservoir cap IVD

Cup 100ml with cap - 04038917113656

No Description
Sarstedt Aktiengesellschaft & Co.KG
75.562.300
In Commercial Distribution

  • 04038917189798 ()
  • 04038917113656 ()
75.562.300

  • Non-evacuated urine specimen container IVD, no additive

Tube with cap, 76x20mm - 04038917083805

No Description
Sarstedt Aktiengesellschaft & Co.KG
60.732
In Commercial Distribution

  • 04038917166010 ()
  • 04038917083805 ()
60.732

  • Assay container IVD, single-use

Archiving Cap with filter - 04038917988278

Archiving Cap with filter
Sarstedt Aktiengesellschaft & Co.KG
65.647.320
In Commercial Distribution

  • 04038917988292 ()
  • 04038917988278 ()


  • Test tube/reservoir cap

PocketPEP Advantage with OxyJET - 10851232007728

A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
D R BURTON HEALTHCARE, LLC
1
In Commercial Distribution

  • 30851232007722 ()
  • 10851232007728 ()
538

  • Incentive spirometer

Genesis MNS with Model-S - M58800101100030

"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Stereotaxis, Inc.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system

VersiHD with GuideMe software - M535NX100010F0

No Description
NXSTAGE MEDICAL, INC.
NX1000-10-F
In Commercial Distribution

  • M535NX100010F0 ()


  • Haemodialysis system, institutional/home-use

VersiHD with GuideMe software - M535NX100016F0

No Description
NXSTAGE MEDICAL, INC.
NX1000-16-F
In Commercial Distribution

  • M535NX100016F0 ()


  • Haemodialysis system, institutional/home-use

VersiHD with GuideMe software - M535NX100010G0

No Description
NXSTAGE MEDICAL, INC.
NX1000-10-G
In Commercial Distribution

  • M535NX100010G0 ()


  • Haemodialysis system, institutional/home-use
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