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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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ML7020 (Plus 10) - 00850724001124

Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome, Sample
MED LOGICS INC
ML7020 (+10)
In Commercial Distribution

  • 00850724001124 ()
  • 10850724001121 ()
ML7020 (+10)

  • Keratome blade, single-use

ML7100 (Minus 10) - 00850724001094

Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkeratome, Sample
MED LOGICS INC
ML7100 (-10)
In Commercial Distribution

  • 00850724001094 ()
  • 10850724001091 ()
ML7100 (-10)

  • Keratome blade, single-use

ML7030 (Minus 10) - 00850724001032

Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample
MED LOGICS INC
ML7030 (-10)
In Commercial Distribution

  • 00850724001032 ()
  • 10850724001039 ()
ML7030 (-10)

  • Keratome blade, single-use

AURA 10 PET-CT - 05430002734026

Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD

Secure-Loop 10 mm - 05060267131416

No Description
XIROS LTD
102-4010
In Commercial Distribution

  • 05060267131416 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable

BONE FILE #10 - D9281052100

No Description
W.H. Holden, Inc.
10-5210
In Commercial Distribution

  • D9281052100 ()


  • Bone file/rasp, reciprocating, single-use

Vivapore 10/20 - 05060602430112

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP2003
In Commercial Distribution

  • 05060602430112 ()
  • 05060602430358 ()


  • Laboratory dialyser

Vivapore 10/20 - 05060602430105

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP2002
In Commercial Distribution

  • 05060602430105 ()
  • 05060602430358 ()


  • Laboratory dialyser

Vivapore 10/20 - 05060602430099

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP2001
In Commercial Distribution

  • 05060602430099 ()
  • 05060602430358 ()


  • Laboratory dialyser

NewLife Intensity 10 - M638AS0994U0

Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options, Re-manufactured.
AIRSEP CORPORATION
AS099-4U
In Commercial Distribution

  • M638AS0994U0 ()


  • Stationary oxygen concentrator
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