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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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Surgical Instrument Guide pin used during OPRA™ Fixture removal. Provides a guiding system to centre the Trephine aligned to the Fixture when used together with Guide Sleeve.
Integrum AB
2617
In Commercial Distribution

  • 07340152102225 ()


  • Internal-external leg prosthesis osseointegration bar
multi use posts connecting stereotactic frame with patient skull , threw screws, during neuro MRI guided FUS treatment Stereotactic Frame Posts ASM001395 (70mmL) ASM001396 (70mmR) ASM001397 (100mmL) ASM001398 (100mmR)
INSIGHTEC LTD
Neuro Stereotactic Frame Posts
In Commercial Distribution

  • 07290015461320 ()

  • Length: 100 Millimeter
  • Length: 70 Millimeter
ASM001395_6_7_8

  • Therapeutic oncological/gynaecological ultrasound system
Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; (unpackaged unit).
CARDIOCOMMAND, INC.
Unpackaged
In Commercial Distribution

  • 00856233005165 ()
0101

  • External pacemaker, transoesophageal pacing
MONITOR MMT-9101 MYSNTRY1 V1.1 EN
MEDTRONIC MINIMED, INC.
MMT-9101
Not in Commercial Distribution

  • 00613994906052 ()


  • General-purpose multi-parameter bedside monitor
SENSOR MMT-7002C 10PK BSA NREFR 21L
MEDTRONIC MINIMED, INC.
MMT-7002C
Not in Commercial Distribution

  • 20613994598404 ()
  • 00613994598400 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
MONITOR CSS7100NA GRDN RLTIME V2.1 EN
MEDTRONIC MINIMED, INC.
CSS7100NA
In Commercial Distribution

  • 00613994349606 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SYSTEM MMT-7708NA CGMS IPRO V1.0 EN
MEDTRONIC MINIMED, INC.
MMT-7708NA
In Commercial Distribution

  • 00613994343604 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
37210
In Commercial Distribution

  • H628372101 ()
37210

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
C22846
In Commercial Distribution

  • 15099590701680 ()
C22846

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; re-manufactured, (unpackaged unit).
CARDIOCOMMAND, INC.
Re-manufactured, unpackaged
In Commercial Distribution

  • 00856233005172 ()
0101-9999

  • External pacemaker, transoesophageal pacing
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