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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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Pointe Scientific, Inc. - 00811727011305

Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus. 40 test
POINTE SCIENTIFIC, INC.
G7540-40
In Commercial Distribution

  • 00811727011305 ()
G7540-40

  • Glycated haemoglobin (HbA1c) IVD, reagent

Medline - 10884389958858

DRIVER, CANNULATED, T20
MEDLINE INDUSTRIES, INC.
MSN30003
In Commercial Distribution

  • 10884389958858 ()
MSN30003

  • Catheter-exchange guidewire holder
  • Bone nail driver

Medline - 10884389957233

DRIVER, CANNULATED, T10
MEDLINE INDUSTRIES, INC.
MSN30002
In Commercial Distribution

  • 10884389957233 ()
MSN30002

  • Bone nail driver
  • Catheter-exchange guidewire holder

Medline - 10884389957240

DRIVER, CANNULATED, T30
MEDLINE INDUSTRIES, INC.
MSN30004
In Commercial Distribution

  • 10884389957240 ()
MSN30004

  • Catheter-exchange guidewire holder
  • Bone nail driver

Medline - 10884389957226

DRIVER, CANNULATED, T8
MEDLINE INDUSTRIES, INC.
MSN30001
In Commercial Distribution

  • 10884389957226 ()
MSN30001

  • Bone nail driver
  • Catheter-exchange guidewire holder

Pointe Scientific, Inc. - 00811727011329

This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 1 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-STD
In Commercial Distribution

  • 00811727011329 ()
G7540-STD

  • Glycated haemoglobin (HbA1c) IVD, calibrator

Pointe Scientific, Inc. Glyco Standard - 00811727014245

This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 1 x 1 ml
POINTE SCIENTIFIC, INC.
13-G7540-STD
In Commercial Distribution

  • 00811727014245 ()
13-G7540-STD

  • Glycated haemoglobin (HbA1c) IVD, calibrator

Pointe Scientific, Inc. Glyco Resin - 00811727014238

Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus. 1 x 120 ml
POINTE SCIENTIFIC, INC.
13-G7540-RES-120
In Commercial Distribution

  • 00811727014238 ()
13-G7540-RES-120

  • Glycated haemoglobin (HbA1c) IVD, reagent

Pointe Scientific, Inc. Gyco Lyse - 00811727014221

Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus. 1 x 30 ml
POINTE SCIENTIFIC, INC.
13-G7540-LYS-30
In Commercial Distribution

  • 00811727014221 ()
13-G7540-LYS-30

  • Glycated haemoglobin (HbA1c) IVD, reagent

Kick 2 Navigation Station EM - 04056481143725

The platform hosts one or more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery (IGS) purposes.
Brainlab AG
18202
In Commercial Distribution

  • 04056481143725 ()


  • Electromagnetic/optical surgical navigation device tracking system
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