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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 prep CAD/CAM No. 34 (A) mesial - EKAV100619770

This is a medical device.
KaVo Dental GmbH
1.006.1977
In Commercial Distribution

  • EKAV100619770 ()
prep CAD CAM No 34 A mesial

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 33 (A) - EKAV100619750

This is a medical device.
KaVo Dental GmbH
1.006.1975
In Commercial Distribution

  • EKAV100619750 ()
micro Tip No 33 A

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 32 (A) - EKAV100619730

This is a medical device.
KaVo Dental GmbH
1.006.1973
In Commercial Distribution

  • EKAV100619730 ()
micro Tip No 32 A

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 28 (A) - EKAV100619650

This is a medical device.
KaVo Dental GmbH
1.006.1965
In Commercial Distribution

  • EKAV100619650 ()
micro Tip No 28 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 27 (A) - EKAV100619630

This is a medical device.
KaVo Dental GmbH
1.006.1963
In Commercial Distribution

  • EKAV100619630 ()
rootplaner Tip No 27 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 26 (A) - EKAV100619610

This is a medical device.
KaVo Dental GmbH
1.006.1961
In Commercial Distribution

  • EKAV100619610 ()
rootplaner Tip No 26 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 25 (A) - EKAV100619590

This is a medical device.
KaVo Dental GmbH
1.006.1959
In Commercial Distribution

  • EKAV100619590 ()
rootplaner Tip No 25 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 24 (A) - EKAV100619570

This is a medical device.
KaVo Dental GmbH
1.006.1957
In Commercial Distribution

  • EKAV100619570 ()
rootplaner Tip No 24 A

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 62 (A) - EKAV100619360

This is a medical device.
KaVo Dental GmbH
1.006.1936
In Commercial Distribution

  • EKAV100619360 ()
paro Tip No 62 A

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 60 (A) - EKAV100619340

This is a medical device.
KaVo Dental GmbH
1.006.1934
In Commercial Distribution

  • EKAV100619340 ()
paro Tip No 60 A

  • Dental surgical power tool motor, pneumatic

EXPERTtorque Mini LUX E677 LN - EKAV100601000

This is a medical device.
KaVo Dental GmbH
1.006.0100
In Commercial Distribution

  • EKAV100601000 ()
E677 LN

  • Dental surgical power tool motor, pneumatic

SONICflex scaler Tip No. 6 (A) - EKAV100589500

This is a medical device.
KaVo Dental GmbH
1.005.8950
In Commercial Distribution

  • EKAV100589500 ()
scaler Tip No 6 A

  • Ultrasonic dental scaling/debridement system

SONICflex scaler Tip No. 5 (A) - EKAV100589490

This is a medical device.
KaVo Dental GmbH
1.005.8949
In Commercial Distribution

  • EKAV100589490 ()
scaler Tip No 5 A

  • Ultrasonic dental scaling/debridement system

ARCUS digma USB - EKAV100523010

This is a medical device.
KaVo Dental GmbH
1.005.2301
In Commercial Distribution

  • EKAV100523010 ()
NA

  • Facebow

InBody - 08809209591980

This is a Handheld Dynamometer
InBody Co., Ltd.
InGrip(IB-HGSm)
In Commercial Distribution

  • 08809209591980 ()


  • Hand dynamometer/pinchmeter, electronic

Gyrus ACMI - 00821925024137

VOKOVIC I-S JOINT REPLACEMENT PLASTIPORE
Gyrus ACMI, LLC
912986
Not in Commercial Distribution

  • 00821925024137 ()


  • Ossicular prosthesis, partial

Millennium - 00190776166113

PIERCE Cheek Retractor . Blade is
Avalign Technologies, Inc.
1-24160
In Commercial Distribution

  • 00190776166113 ()


  • Hand-held surgical retractor, reusable

iClean - 26974488990062

The breaking point is 90mm.
Huachenyang (Shenzhen) Technology Co., Ltd
CY-96000
In Commercial Distribution

  • 36974488990069 ()
  • 26974488990062 ()
  • 16974488990065 ()


  • General-purpose absorbent tip applicator/swab, single-use

Lumecca I - 07290016633955

Lumecca-I is an IPL applicator
INMODE M.D LTD
AG610797A
In Commercial Distribution

  • 07290016633955 ()
AG610797A

  • Multi-modality skin surface treatment system

iClean - 16974488990096

The breaking point is 80mm.
Huachenyang (Shenzhen) Technology Co., Ltd
CY-96000
In Commercial Distribution

  • 26974488990093 ()
  • 16974488990096 ()
  • 06974488990099 ()


  • General-purpose absorbent tip applicator/swab, single-use
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