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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JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 11G X4
CAREFUSION 2200, INC
TJM4011
In Commercial Distribution

  • 50885403044586 ()
  • 10885403044588 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
TJM4011

  • Bone marrow biopsy needle, single-use
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 13G X3.5
CAREFUSION 2200, INC
TJM3513
In Commercial Distribution

  • 50885403044548 ()
  • 10885403044540 ()

  • Needle Gauge: 13 Gauge
  • Length: 3.5 Inch
TJM3513

  • Bone marrow biopsy needle, single-use
PC-ECG Wireless Acquisition Device (Rev.01) for Stress-Test ECG with IEC type labelling
NORAV MEDICAL LTD.
1200W1
In Commercial Distribution

  • 07290110253752 ()
1200W1-D-00E-01

  • Electrocardiography telemetric monitoring system transmitter
PC-ECG Wireless Acquisition Device (Rev.01) for Stress-Test ECG with AHA type labelling
NORAV MEDICAL LTD.
1200W1
In Commercial Distribution

  • 07290110253769 ()
1200W1-D-00U-01

  • Electrocardiography telemetric monitoring system transmitter
Drill bit D4.5 L300 conical
WITTENSTEIN intens GmbH
DRBI D4.5 L300 CO
Not in Commercial Distribution

  • 04260170140692 ()
60001605

  • Orthopaedic bur, reusable
Remanufactured Stat Profile pHOx Ultra CO-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420171 ()
  • 00385480420174 ()
42017

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Ultra Co-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420133 ()
  • 00385480420136 ()
42013

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Magnetic stimulation coil
Tonica Elektronik A/S
Coil Cool B-70 CO
In Commercial Distribution

  • 05713484020468 ()
9016E0181

  • Magnetic neural stimulation system
Sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 GORGON 51S CO
In Commercial Distribution

  • 18435736022818 ()
  • 08435736022811 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 GORGON 51D CO
In Commercial Distribution

  • 18435736022801 ()
  • 08435736022804 ()


  • Spectacle frame
Sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 AVINY3 51S CO
In Commercial Distribution

  • 18435736007006 ()
  • 08435736007009 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 AVINY3 51D CO
In Commercial Distribution

  • 18435736006993 ()
  • 08435736006996 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
5 BRUT31 47O CO
In Commercial Distribution

  • 18435736061992 ()
  • 08435736061995 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 NERI 49O CO
In Commercial Distribution

  • 18435685008604 ()
  • 08435685008607 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 FLUX 53O CO
In Commercial Distribution

  • 18435685006600 ()
  • 08435685006603 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 AURA 55O CO
In Commercial Distribution

  • 18435685004569 ()
  • 08435685004562 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 FLUX 51O CO
In Commercial Distribution

  • 18435685006280 ()
  • 08435685006283 ()


  • Spectacle frame
sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 EPIC 52S CO
In Commercial Distribution

  • 18435736076224 ()
  • 08435736076227 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 EPIC 52D CO
In Commercial Distribution

  • 18435736076217 ()
  • 08435736076210 ()


  • Spectacle frame
HANDLE AXIAL MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable
Richard Wolf GmbH
83930084
In Commercial Distribution

  • 04055207026656 ()
83930084

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Basic Tray (Triple-Lumen) (with Microintroducer)
Bard Access Systems, Inc.
9395118Q
In Commercial Distribution

  • 10801741035910 ()
  • 00801741035913 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9395118Q

  • Peripherally-inserted central venous catheter
This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
PS-BU-046
In Commercial Distribution

  • 04589698450473 ()


  • Surgical instrument assist arm system, power-adjusted
This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
PS-BU-045
In Commercial Distribution

  • 04589698450466 ()


  • Surgical instrument assist arm system, power-adjusted
This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
PS-SU-040
In Commercial Distribution

  • 04589698450459 ()


  • Surgical instrument assist arm system, power-adjusted
This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
PSMP
In Commercial Distribution

  • 04589698450404 ()


  • Surgical instrument assist arm system, power-adjusted
Axial length measurement probe with an integrated laser pointer for biometry: - Ensuring the acquisition in the visual axis - Increasing the patient cooperation - Accelerating the speed of acquisition of A scans
QUANTEL MEDICAL
TP-02-las
In Commercial Distribution

  • 03700542625101 ()


  • Ophthalmic ultrasound imaging transducer
No Description
OCULAR INSTRUMENTS, INC.
OSIG 12173
In Commercial Distribution

  • 00630238118132 ()
  • 00630238121736 ()


  • Vitrectomy contact lens, single-use
No Description
W.H. Holden, Inc.
10-5163-65HF
In Commercial Distribution

  • D92810516365HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-55HF
In Commercial Distribution

  • D92810516355HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-50HF
In Commercial Distribution

  • D92810516350HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-45HF
In Commercial Distribution

  • D92810516345HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-42HF
In Commercial Distribution

  • D92810516342HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-41HF
In Commercial Distribution

  • D92810516341HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-40HF
In Commercial Distribution

  • D92810516340HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-38HF
In Commercial Distribution

  • D92810516338HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-35HF
In Commercial Distribution

  • D92810516335HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-32HF
In Commercial Distribution

  • D92810516332HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-30HF
In Commercial Distribution

  • D92810516330HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5163-28HF
In Commercial Distribution

  • D92810516328HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5113HF
In Commercial Distribution

  • D928105113HF0 ()


  • Paranasal sinus curette
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