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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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Kinos Axiom - 00860007995118

Kinos Axiom Flat Top Talar Implant, Size 2, Left
Restor3d, Inc.
2831.0112
Not in Commercial Distribution

  • 00860007995118 ()


  • Coated ankle tibia prosthesis

Kinos Axiom - 00860007995101

Kinos Axiom Flat Top Talar Implant, Size 1, Left
Restor3d, Inc.
2831.0111
Not in Commercial Distribution

  • 00860007995101 ()


  • Coated ankle tibia prosthesis

WavelyDx Middle Ear Fluid CMD iOS Application - 00860007953712

The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
Wavely Diagnostics, Inc.
SWA-1262
In Commercial Distribution

  • 00860007953712 ()
SWA-1262

  • Impedance audiometer

Wavely Ear Tip - 00860007953705

The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
Wavely Diagnostics, Inc.
1300-05
In Commercial Distribution

  • 00860007953705 ()
  • 00860007953798 ()
1300-05

  • Impedance audiometer

HU-FRIEDY - 10889950019389

Grisdale Bone Condenser, Black Line
HU-FRIEDY MFG. CO., LLC
PLGGR1X
In Commercial Distribution

  • 10889950019389 ()
PLGGR1X

  • Endodontic filling material condenser

HU-FRIEDY - 10889950019372

Grisdale Bone Condenser
HU-FRIEDY MFG. CO., LLC
PLGGR1S6
In Commercial Distribution

  • 10889950019372 ()
PLGGR1S6

  • Endodontic filling material condenser

HU-FRIEDY - 10889950019365

GRISDALE BONE CONDENSER 8-10-13-15-18
HU-FRIEDY MFG. CO., LLC
PLGGR1
In Commercial Distribution

  • 10889950019365 ()
PLGGR1

  • Endodontic filling material condenser

HU-FRIEDY - 10889950019099

3R RD CONE PK THOMAS #6 HDL
HU-FRIEDY MFG. CO., LLC
PKT3R6
In Commercial Distribution

  • 10889950019099 ()
PKT3R6

  • Dental wax carver

HU-FRIEDY - 10889950019082

#3R Round Cone P.K. Thomas Waxing Inst.
HU-FRIEDY MFG. CO., LLC
PKT3R
In Commercial Distribution

  • 10889950019082 ()
PKT3R

  • Dental wax carver

HU-FRIEDY - 10889950019037

1 K-N Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
PKN16
In Commercial Distribution

  • 10889950019037 ()
PKN16

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950019020

152 K-N Periosteal, Black Line
HU-FRIEDY MFG. CO., LLC
PKN152X
In Commercial Distribution

  • 10889950019020 ()
PKN152X

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950019013

152 K-N Periosteal, Black Line
HU-FRIEDY MFG. CO., LLC
PKN152SX
In Commercial Distribution

  • 10889950019013 ()
PKN152SX

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950019006

#152 Kramer-Nevins Periosteal
HU-FRIEDY MFG. CO., LLC
PKN152S6
In Commercial Distribution

  • 10889950019006 ()
PKN152S6

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018993

#152 K-N Periosteal #6 Handle
HU-FRIEDY MFG. CO., LLC
PKN1526
In Commercial Distribution

  • 10889950018993 ()
PKN1526

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018986

#152 K-N Periosteal
HU-FRIEDY MFG. CO., LLC
PKN152
In Commercial Distribution

  • 10889950018986 ()
PKN152

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018979

#1 K-N Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
PKN1
In Commercial Distribution

  • 10889950018979 ()
PKN1

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018962

Jovanovic Mini Periodontal Chisel, 3mm
HU-FRIEDY MFG. CO., LLC
PJO/3M6
In Commercial Distribution

  • 10889950018962 ()
PJO/3M6

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950018931

Jovanovic Mini Periodontal Chisel, 2mm
HU-FRIEDY MFG. CO., LLC
PJO/2M6
In Commercial Distribution

  • 10889950018931 ()
PJO/2M6

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950018825

PERIOSTEAL PH2MBH WITH SATIN STEEL HDL
HU-FRIEDY MFG. CO., LLC
PH26M
In Commercial Distribution

  • 10889950018825 ()
PH26M

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018818

#2 Hourigan/Mod Woodson Periosteal
HU-FRIEDY MFG. CO., LLC
PH26
In Commercial Distribution

  • 10889950018818 ()
PH26

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018801

#2 Hourigan Periosteal/Mod Woodson
HU-FRIEDY MFG. CO., LLC
PH2
In Commercial Distribution

  • 10889950018801 ()
PH2

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018795

#1 Hourigan Periosteal - #23 Serrated
HU-FRIEDY MFG. CO., LLC
PH1
In Commercial Distribution

  • 10889950018795 ()
PH1

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018788

GRISDALE PERIOSTEAL ELEVATOR
HU-FRIEDY MFG. CO., LLC
PGR1
In Commercial Distribution

  • 10889950018788 ()
PGR1

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018719

Freer Nasal Periosteal
HU-FRIEDY MFG. CO., LLC
PFN
In Commercial Distribution

  • 10889950018719 ()
PFN

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018603

PFI#1 HEIDMANN SPATULA, SATIN STEEL
HU-FRIEDY MFG. CO., LLC
PFIHS16
In Commercial Distribution

  • 10889950018603 ()
PFIHS16

  • Dental spatula, reusable

HU-FRIEDY - 10889950018221

Sinus Lift Inst, Single End #6 Handle
HU-FRIEDY MFG. CO., LLC
PESIM16
In Commercial Distribution

  • 10889950018221 ()
PESIM16

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018214

PERIOSTEAL, SINGLE END (IMP6688K)
HU-FRIEDY MFG. CO., LLC
PESIM1
In Commercial Distribution

  • 10889950018214 ()
PESIM1

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950018207

Wise Periotome, Black Line
HU-FRIEDY MFG. CO., LLC
PEREURX
In Commercial Distribution

  • 10889950018207 ()
PEREURX

  • Periotome, reusable

HU-FRIEDY - 10889950018191

SATIN STEEL Periotome-Dr. Wise
HU-FRIEDY MFG. CO., LLC
PEREUR6
In Commercial Distribution

  • 10889950018191 ()
PEREUR6

  • Periotome, reusable

HU-FRIEDY - 10889950018184

Demirel Periosteal, #6 Short Hdl
HU-FRIEDY MFG. CO., LLC
PDEMIRELS6
In Commercial Distribution

  • 10889950018184 ()
PDEMIRELS6

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017484

Benque Periosteal, Satin Steel Handle
HU-FRIEDY MFG. CO., LLC
PBQ6
In Commercial Distribution

  • 10889950017484 ()
PBQ6

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017477

Benque Periosteal
HU-FRIEDY MFG. CO., LLC
PBQ
In Commercial Distribution

  • 10889950017477 ()
PBQ

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017453

9 Molt Periosteal Elevator, Black Line
HU-FRIEDY MFG. CO., LLC
P9X
In Commercial Distribution

  • 10889950017453 ()
P9X

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017446

9H Howard Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
P9H6
In Commercial Distribution

  • 10889950017446 ()
P9H6

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017439

#9H Howard Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
P9H
In Commercial Distribution

  • 10889950017439 ()
P9H

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017422

9A Allen Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
P9A6
In Commercial Distribution

  • 10889950017422 ()
P9A6

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017415

#9A Allen Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
P9A
In Commercial Distribution

  • 10889950017415 ()
P9A

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017408

9 Molt Periosteal Elevator
HU-FRIEDY MFG. CO., LLC
P96
In Commercial Distribution

  • 10889950017408 ()
P96

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017392

P9/PA DE Periosteal #6 Handle
HU-FRIEDY MFG. CO., LLC
P9/PA6
In Commercial Distribution

  • 10889950017392 ()
P9/PA6

  • Periosteal elevator, reusable

HU-FRIEDY - 10889950017385

9/PA DE PERIOSTEAL
HU-FRIEDY MFG. CO., LLC
P9/PA
In Commercial Distribution

  • 10889950017385 ()
P9/PA

  • Periosteal elevator, reusable
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