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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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No Description
GALEMED CORPORATION
H050-M
In Commercial Distribution

  • 44710810100497 ()
  • 04710810100499 ()
Hyperinflation System 0.5L with Mask

  • Anaesthesia face mask, reusable
No Description
GALEMED CORPORATION
H025-M
In Commercial Distribution

  • 44710810100480 ()
  • 04710810100482 ()
Hyperinflation System 0.25L with Mask

  • Anaesthesia face mask, reusable
Adapter, Flushing with Luer Lock with holding-strap ValveGate™
Geister Medizintechnik GmbH
34-7499B
In Commercial Distribution

  • 04057034120903 ()
34-7499B

  • Heart valve annulus sizer, reusable
Retractor, Spinal, ring-handle with double-hinge with catch PEEK SpineControl™
Geister Medizintechnik GmbH
29-3100.PK
In Commercial Distribution

  • 04057034098042 ()
29-3100.PK

  • Surgical retraction system mounting frame, reusable
Retractor, Spinal, ring-handle with double-hinge with catch SpineControl™
Geister Medizintechnik GmbH
29-3100
In Commercial Distribution

  • 04057034098035 ()
29-3100

  • Surgical retraction system mounting frame, reusable
The Rabbit FluoroDetector FITC with FluoroMounter with DAPI kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB03200 ()
BSB 0320

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The Rabbit FluoroDetector FITC with FluoroMounter with DAPI kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB03190 ()
BSB 0319

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The Rabbit FluoroDetector FITC with FluoroMounter with DAPI is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB03180 ()
BSB 0318

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
This instrument is used to grasp, retract, or stabilize tissue.
DAUD JEE MFG. CO
DT50-500095-1
In Commercial Distribution

  • G006DT5050009510 ()
DT50-500095-1

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
This instrument is used to grasp, retract, or stabilize tissue.
DAUD JEE MFG. CO
DT50-500095
In Commercial Distribution

  • G006DT505000950 ()
DT50-500095

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
Lonza Walkersville, Inc.
12-743F
In Commercial Distribution

  • 00840075402831 ()
12-743F

  • Ex vivo cell culture medium
ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
Edwards Lifesciences LLC
AIQSFM6C502
In Commercial Distribution

  • 50690103205836 ()
  • 00690103205831 ()
AIQSFM6C502

  • Intravenous line sensor, gravity infusion
SonoVision Accessory Kit Second Dilator
Tissue Differentiation Intelligence LLC
100034
In Commercial Distribution

  • 00860001239386 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Initial Dilator
Tissue Differentiation Intelligence LLC
100033
In Commercial Distribution

  • 00860001239379 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Dilator Guide - Double
Tissue Differentiation Intelligence LLC
100030
In Commercial Distribution

  • 00860001239362 ()


  • Interventional radiology percutaneous-access kit, reusable
Beluga1 Imaging Probe
Tissue Differentiation Intelligence LLC
100005
In Commercial Distribution

  • 00860001239348 ()


  • Surgical ultrasound imaging transducer
SonoVision Accessory Kit Dilator Guide - Triple
Tissue Differentiation Intelligence LLC
100022
In Commercial Distribution

  • 00860001239331 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Stabilzer Tube
Tissue Differentiation Intelligence LLC
100021
In Commercial Distribution

  • 00860001239324 ()


  • Interventional radiology percutaneous-access kit, reusable
CABLE 203CXC COAXIAL UMBIL BOX 12 ROHS
MEDTRONIC, INC.
203CXC
In Commercial Distribution

  • 20643169950157 ()
  • 00643169950153 ()


  • Liquid nitrous oxide coaxial tubing
CABLE 203CX COAXIAL UMBILICAL ROHS
MEDTRONIC, INC.
203CX
In Commercial Distribution

  • 00643169950146 ()


  • Liquid nitrous oxide coaxial tubing
SHEATH 990065 FLEXCATH SELECT 10 FR 65CM
MEDTRONIC, INC.
990065
Not in Commercial Distribution

  • 00643169688858 ()

  • Usable length 65 cm
  • Dilator inner diameter 1 mm
  • Sheath inner diameter 10 Fr (3.3 mm)


  • Haemostasis valve
CATHETER 227F5 FREEZOR XTRA5 LG 7F
MEDTRONIC, INC.
227F5
In Commercial Distribution

  • 00643169672482 ()

  • catheter curve 60mm
  • Catheter Gauge: 7.0 French
  • Length: 108.0 Centimeter
  • catheter tip length 6mm


  • Cardiac cryosurgical system catheter
CATHETER 227F3 FREEZOR XTRA3 MED7F
MEDTRONIC, INC.
227F3
In Commercial Distribution

  • 00643169672475 ()

  • Length: 108.0 Centimeter
  • catheter tip length 6mm
  • Catheter Gauge: 7.0 French
  • catheter curve 55mm


  • Cardiac cryosurgical system catheter
CATHETER 227F1 FREEZOR XTRA1 SH 7F
MEDTRONIC, INC.
227F1
In Commercial Distribution

  • 00643169672468 ()

  • catheter curve 49mm
  • catheter tip length 6mm
  • Catheter Gauge: 7.0 French
  • Length: 108.0 Centimeter


  • Cardiac cryosurgical system catheter
Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • Haemodialysis system dialysate pyrogen filter
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer
No Description
SEBIA
4757
In Commercial Distribution

  • 03607360047576 ()
4757

  • Haemoglobin detection IVD, control
MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
SEBIA
2578
In Commercial Distribution

  • 03607360025789 ()
2578

  • Microplate IVD
No Description
SEBIA
2563
In Commercial Distribution

  • 03607360025635 ()
2563

  • Multiple haemoglobin subtype IVD, kit, electrophoresis
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