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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The BeauTis Light S is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis Light S is a medical device that must be operated by medical personnel. The BeauTis Light S is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 20 min operation, 5 min rest for BeauTis Light S
Osstem Implant Co.,Ltd.
BeauTis Light S
In Commercial Distribution

  • 08800000995762 ()


  • Tooth-bleaching acceleration unit
HF CONNECTION CABLE BIPO L 5M for bipolar resection, 2 PIN plug, Valleylab plug with RFID identification, reusable
Richard Wolf GmbH
8108253
In Commercial Distribution

  • 04055207063354 ()

  • Length: 5 Meter
8108253

  • Electrical-only medical device connection cable, reusable
HF CONNECTION CABLE BIPO L 3M for bipolar resection, 2 PIN plug, Valleylab plug with RFID identification, reusable
Richard Wolf GmbH
8108233
In Commercial Distribution

  • 04055207063347 ()

  • Length: 3 Meter
8108233

  • Electrical-only medical device connection cable, reusable
Ergonomic Highly Rigid Plastic Ring Handle With Ratchet And Ratchet Activating Release Lever Rotation Module And HF Connection
SONTEC INSTRUMENTS, INC.
2901-094
In Commercial Distribution

  • 00192896114074 ()


  • Laparoscopic surgery handle
HANDLE PISTOL SHAPED MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable
Richard Wolf GmbH
83930074
In Commercial Distribution

  • 04055207026625 ()
83930074

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HANDLE PISTOL SHAPED MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable
Richard Wolf GmbH
83930073
In Commercial Distribution

  • 04055207026618 ()
83930073

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
PEDERSON VAGINAL SPECULA FIG. 3, BLUE COATED, WITH SMOKE TUBE 120 X 25 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1012.03
In Commercial Distribution

  • 04049047654094 ()
GU.1012.03

  • Vaginal speculum, reusable
GRAVE VAGINAL SPECULA FIG. 3, BLUE COATED, WITH SMOKE TUBE 115 X 33 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1002.03
In Commercial Distribution

  • 04049047654049 ()
GU.1002.03

  • Vaginal speculum, reusable
GRAVE VAGINAL SPECULA FIG. 2, BLUE COATED, WITH SMOKE TUBE 95 X 35 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1002.02
In Commercial Distribution

  • 04049047654032 ()
GU.1002.02

  • Vaginal speculum, reusable
PEDERSON VAGINAL SPECULA FIG. 2, BLUE COATED, WITH SMOKE TUBE 100 X 22 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1012.02
In Commercial Distribution

  • 04049047654018 ()
GU.1012.02

  • Vaginal speculum, reusable
PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen) (with Microintroducer)
Bard Access Systems, Inc.
9395108QD
In Commercial Distribution

  • 10801741035903 ()
  • 00801741035906 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
9395108QD

  • Peripherally-inserted central venous catheter
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400786 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Jamshidi® Bone Marrow Biopsy/Aspiration Needle,With Marrow Acquisition Cradle, 11G x 10cm
CAREFUSION 2200, INC
MICH4011
In Commercial Distribution

  • 50885403103184 ()
  • 10885403103186 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
MICH4011

  • Bone marrow biopsy procedure kit
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 8G X 6
CAREFUSION 2200, INC
TJM6008
In Commercial Distribution

  • 50885403044593 ()
  • 10885403044595 ()

  • Length: 6 Inch
  • Needle Gauge: 8 Gauge
TJM6008

  • Bone marrow biopsy needle, single-use
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 8G X 4
CAREFUSION 2200, INC
TJM4008
In Commercial Distribution

  • 50885403044562 ()
  • 10885403044564 ()

  • Needle Gauge: 8 Gauge
  • Length: 4 Inch
TJM4008

  • Bone marrow biopsy needle, single-use
Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with AHA type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254636 ()
NR314T-D-00U-02

  • Electrocardiographic ambulatory recorder
Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with AHA type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254629 ()
NR314T-D-00U-01

  • Electrocardiographic ambulatory recorder
Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with IEC type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254612 ()
NR314T-D-00E-02

  • Electrocardiographic ambulatory recorder
Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with IEC type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110253332 ()
NR314T-D-00E-01

  • Electrocardiographic ambulatory recorder
Norav PC-ECG 1200 Series wireless Acquisition Device for Resting ECG with AHA type labelling.
NORAV MEDICAL LTD.
Blue ECG
In Commercial Distribution

  • 07290110250607 ()
  • 7290110250713 ()
BLUECG-D-00U-01

  • Electrocardiography telemetric monitoring system transmitter
ELI 280 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead AHA lead set, set of 10 adapter clips, UTK wireless receiver.
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094261424 ()
UPG280-B-WAM-A

  • Electrocardiograph, professional, multichannel
ELI 280 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead IEC lead set, set of 10 adapter clips, UTK wireless receiver.
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094261417 ()
UPG280-B-WAM-B

  • Electrocardiograph, professional, multichannel
XScribe 5 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead AHA lead set, set of 10 adapter clips, UTK wireless receiver.
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261264 ()


  • Electrocardiographic lead set, reusable
XScribe 5 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead IEC lead set, set of 10 adapter clips, UTK wireless receiver.
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261257 ()


  • Electrocardiographic lead set, reusable
The OmnifyXR is an adjunctive augmented reality display to interventional x-ray imaging systems. The system is comprised of a commercial off-the-shelf augmented reality display, wirelessly connected to a server that interfaces with the imaging system. It is intended to simultaneously display up to four video streams and a 3D surface model holographically using an augmented reality headset, and provides functions for display of the video streams, display of the 3D surface, and remote collaboration. The system allows for the management and selection of the video streams displayed and allows for adjusting position and orientation of the 3D surface model in the augmented reality display. The OmnifyXR system is capable of telemedicine collaboration, allowing verbal and visual collaboration with a remote healthcare professional by sharing the augmented reality display and audio. The device is intended to be used as a collaborative integration system. It is an open platform that combines input from key devices in the interventional suite and provides this data to the user in a simplified and efficient manner. It is intended for use by trained proceduralists in clinical intervention and for applications where imaging is currently used.
Mediview Xr, Inc.
OXR-SYS
In Commercial Distribution

  • 00850044606061 ()


  • Medical image management system
  • Multidisciplinary medical image management software
No Description
VIEWRAY INCORPORATED
23820
In Commercial Distribution

  • 00868029000391 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
VIEWRAY INCORPORATED
14774
In Commercial Distribution

  • 00868029000360 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
VIEWRAY INCORPORATED
14775
In Commercial Distribution

  • 00868029000353 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
VIEWRAY INCORPORATED
20000-01
In Commercial Distribution

  • 00868029000346 ()


  • Stereotactic teletherapy radionuclide system, MRI-imaging
  • Linear accelerator system
No Description
VIEWRAY INCORPORATED
12981
In Commercial Distribution

  • 00868029000315 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
VIEWRAY INCORPORATED
11765
In Commercial Distribution

  • 00868029000308 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
VIEWRAY INCORPORATED
A3i
In Commercial Distribution

  • 00850036816027 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
VIEWRAY INCORPORATED
20000
In Commercial Distribution

  • 10868029000305 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
Altor Safety N95 Cup Style Respirator, Disposable Surgical N95 Respirator. Sold by Altor Safety, Manufactured by Louis M. Gerson Co., Inc.
LOUIS M. GERSON CO.
1730
In Commercial Distribution

  • 10850019086154 ()
  • 00850019086157 ()
  • 00044585817301 ()
62210

  • Surgical/medical respirator, non-antimicrobial, single-use
Grasping forceps serrated with spoon, Ø5mm, WL 330mm, double action jaw, shaft insulated, plastic handle, male HF- connection, detachable
Hermann Medizintechnik GmbH
H41-533-683
In Commercial Distribution

  • 04059453005663 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.
FOCUS SURGERY INC
202-17000-0012
In Commercial Distribution

  • 00868108000229 ()


  • Ultrasonic hyperthermia system
Micro scissors, rotatable, single-action, 5.0mm diameter, 330.0mm working length, straight blades, sharp tips, carbon fiber ring handle, HF connection
AMBLER SURGICAL CORP.
Micro scissors
In Commercial Distribution

  • 00190660167929 ()
98-250

  • Rigid endoscopic scissors, reusable
Micro scissors, rotatable, single-action, 5.0mm diameter, 330.0mm working length, curved blades, sharp tips, carbon fiber ring handle, HF connection
AMBLER SURGICAL CORP.
Micro scissors
In Commercial Distribution

  • 00190660167912 ()
98-249

  • Rigid endoscopic scissors, reusable
Micro scissors, rotatable, double-action, 5.0mm diameter, 330.0mm working length, curved blades, sharp tips, carbon fiber ring handle, HF connection
AMBLER SURGICAL CORP.
Micro scissors
In Commercial Distribution

  • 00190660167905 ()
98-248

  • Rigid endoscopic scissors, reusable
Micro scissors, non-rotatable, single-action, 5.0mm diameter, 330.0mm working length, straight blades, sharp tips, carbon fiber ring handle, HF connection
AMBLER SURGICAL CORP.
Micro scissors
In Commercial Distribution

  • 00190660167899 ()
98-247

  • Rigid endoscopic scissors, reusable
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