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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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SONICflex paro Tipset - EKAV057103710

This is a medical device.This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.0371
In Commercial Distribution

  • EKAV057103710 ()
paro Tipset

  • Ultrasonic dental scaling/debridement system

MULTIflex Coupling Midwest - EKAV055313900

This is a medical device.This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.553.1390
In Commercial Distribution

  • EKAV055313900 ()
Midwest

  • Dental power tool system handpiece, pneumatic

DiLumen Is Endolumenal Interventional Scissors - 00865309000270

The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
LUMENDI LLC
DiLumen Is 95 cm
In Commercial Distribution

  • 00865309000270 ()
D-3100

  • Flexible endoscopic scissors, single-use

DiLumen Is Endolumenal Interventional Scissors - 00865309000263

The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
LUMENDI LLC
DiLumen Is 140 cm
In Commercial Distribution

  • 00865309000263 ()
D-3101

  • Flexible endoscopic scissors, single-use

pearltec - 07640178061668

Convenience Kit. Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient's skin. Non-Sterile and not to be used in the sterile field.
Pearl Technology AG
Positioning KIT IS Basic
In Commercial Distribution

  • 07640178061668 ()
5014

  • Radiological general body-part positioner

pearltec - 07640178061651

Convenience Kit. Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient's skin. Non-Sterile and not to be used in the sterile field.
Pearl Technology AG
Positioning KIT IS Advanced
In Commercial Distribution

  • 07640178061651 ()
5013

  • Radiological general body-part positioner

Blue Beacon(TM) GI Marker - 06932503562065

Product is dark blue solution, the concentration is 0.8%, the content is 10ml. Initial packaging is the vial.
Micro-Tech (Nanjing) Co., Ltd.
DYZ-08-10
In Commercial Distribution

  • 16932503562062 ()
  • 06932503562065 ()
  • 26932503562069 ()

  • Total Volume: 10 Milliliter


  • Tissue marking ink

MT - 06932503562058

Product is dark blue solution, the concentration is 0.4%, the content is 10ml. Initial packaging is the vial
Micro-Tech (Nanjing) Co., Ltd.
DYZ-04-10
Not in Commercial Distribution

  • 16932503562055 ()
  • 06932503562058 ()
  • 26932503562052 ()


  • Tissue marking ink

Blue Beacon(TM) GI Marker - 06932503562027

Product is dark blue solution, the concentration is 0.4%, the content is 5ml. Initial packaging is the syringe.
Micro-Tech (Nanjing) Co., Ltd.
P-DYZ-04-05
In Commercial Distribution

  • 16932503562024 ()
  • 06932503562027 ()
  • 26932503562021 ()

  • Total Volume: 5 Milliliter


  • Tissue marking ink

Blue Beacon(TM) GI Marker - 06932503562010

Product is dark blue solution, the concentration is 0.4%, the content is 15ml. Initial packaging is the vial.
Micro-Tech (Nanjing) Co., Ltd.
DYZ-04-15
In Commercial Distribution

  • 16932503562017 ()
  • 06932503562010 ()
  • 26932503562014 ()

  • Total Volume: 15 Milliliter


  • Tissue marking ink

EndoINK(TM) Endoscopic Marker - 06932503562720

Product is black suspension, the content is 10ml. Initial packaging is the syringe.
Micro-Tech (Nanjing) Co., Ltd.
ENK-10-05
In Commercial Distribution

  • 16932503562727 ()
  • 06932503562720 ()
  • 26932503562724 ()

  • Total Volume: 10 Milliliter


  • Injectable charcoal tattoo marker

EndoINK(TM) Endoscopic Marker - 06932503562713

Product is black suspension, the content is 5ml. Initial packaging is the syringe.
Micro-Tech (Nanjing) Co., Ltd.
ENK-05-05
In Commercial Distribution

  • 16932503562710 ()
  • 06932503562713 ()
  • 26932503562717 ()

  • Total Volume: 5 Milliliter


  • Injectable charcoal tattoo marker

SONICflex prep ceram Tip No. 52 A - EKAV100619860

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.006.1986
In Commercial Distribution

  • EKAV100619860 ()
prep ceram Tip No 52 A

  • Ultrasonic dental scaling/debridement system

QUATTROcare plus Spray AMERICA 2141 (Set) - EKAV100545240

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.005.4524
In Commercial Distribution

  • EKAV100545240 ()
AMERICA 2141 Set

  • Dental handpiece maintenance unit

INTRAmatic 23 ES - EKAV100453800

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.5380
In Commercial Distribution

  • EKAV100453800 ()
23 ES

  • Dental power tool system handpiece, line-powered

CAD-CAM mesial gebogen No. 34 - EKAV100219840

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.1984
In Commercial Distribution

  • EKAV100219840 ()
mesial gebogen No 34

  • Ultrasonic dental scaling/debridement system

INTRA Head CL 3 - EKAV100189930

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.001.8993
In Commercial Distribution

  • EKAV100189930 ()
CL 3

  • Dental power tool system handpiece, line-powered

INTRA Handpiece C09 - EKAV100122780

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.001.2278
In Commercial Distribution

  • EKAV100122780 ()
C09

  • Dental power tool system handpiece, line-powered

SONICflex cari-ex TC Tipset - EKAV100073790

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.000.7379
In Commercial Distribution

  • EKAV100073790 ()
cari ex TC Tipset

  • Ultrasonic dental scaling/debridement system

SONICflex cari-ex 1.2 No. 43 - EKAV100071670

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.000.7167
In Commercial Distribution

  • EKAV100071670 ()
cari ex 1 2 No 43

  • Ultrasonic dental scaling/debridement system

SONICflex endo Tip No. 70 - EKAV100058210

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.000.5821
In Commercial Distribution

  • EKAV100058210 ()
endo Tip No 70

  • Ultrasonic dental scaling/debridement system

SONICflex 2003 L - EKAV100042430

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.000.4243
In Commercial Distribution

  • EKAV100042430 ()
2003 L

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 61 - EKAV057174120

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.7412
In Commercial Distribution

  • EKAV057174120 ()
paro Tip No 61

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 60 - EKAV057174020

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.7402
In Commercial Distribution

  • EKAV057174020 ()
paro Tip No 60

  • Ultrasonic dental scaling/debridement system

SONICflex bevel Tip No. 59 - EKAV057173820

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.7382
In Commercial Distribution

  • EKAV057173820 ()
bevel Tip No 59

  • Ultrasonic dental scaling/debridement system

SONICflex retro Tip No. 56 - EKAV057173220

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.7322
In Commercial Distribution

  • EKAV057173220 ()
retro Tip No 56

  • Ultrasonic dental scaling/debridement system

SONICflex prep gold Tip No. 49 - EKAV057172120

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.7212
In Commercial Distribution

  • EKAV057172120 ()
prep gold Tip No 49

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 30 - EKAV057168110

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.6811
In Commercial Distribution

  • EKAV057168110 ()
micro Tip No 30

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 25 - EKAV057156310

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5631
In Commercial Distribution

  • EKAV057156310 ()
rootplaner Tip No 25

  • Ultrasonic dental scaling/debridement system

SONICflex retro, left - EKAV057156010

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5601
In Commercial Distribution

  • EKAV057156010 ()
retro left

  • Ultrasonic dental scaling/debridement system
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