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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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Audyx - 07290017820019

Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer

PDT, Inc. - 00813677024947

Kit Includes: (T009D-L) D-Series FlipTop™ Cassette - LiftOut Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R245) Cone Socket Mirror Handle (R375) Mixing Spatula-Applicator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium
PDT, INC.
R933 PDT Cement (Crown Seating) Kit
In Commercial Distribution

  • 00813677024947 ()
R933

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe

Radiology Information Systems, Inc. - 00860009490604

PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation

PDT, Inc. - 00813677025005

Kit Includes: (R006) 11-12 Amazing Gracey™ Extended Reach Mini (R007) 13-14 Amazing Gracey™ Extended Reach Mini (R064) Columbia 13-14 (R130S) Jack B. Nimble® (R138) Montana Jack® (R224) 23 Explorer-Williams O Probe (R245) Cone Socket Mirror Handle (T050) #5 Mirror (15/16")
PDT, INC.
R971 Just Be Nice Hygiene Kit
In Commercial Distribution

  • 00813677025005 ()
R971

  • Dental mirror, reusable
  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle

PDT, Inc. - 00813677024848

Kit Includes: T007B-D B-Series FlipTop™ Cassette - Double Rack 14 R067 Columbia 4L-4R R080 Langer 3-4 R090 H5-L5 R138 Montana Jack® R167 11-12 ODU Explorer R216 ACE™-12 Short Probe R245 Cone Socket Mirror Handle T040 Cotton Pliers T050 #5 Mirror (15/16")
PDT, INC.
R915 PDT SRP C Kit
In Commercial Distribution

  • 00813677024848 ()
R915

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, reusable

PDT, Inc. - 00813677024473

Kit Includes: T009D-F FlipTop™ Cassette 'D' - Fixed Rack 9 R245 Mirror Handle (Cone-Socket) T050 #5 Front Surface Mirror, Cone-Socket, (15/16') R166 Explorer 5 R138R Montana Jack® Rigid R375 Mixing Spatula/Applicator T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T040 Tweezers COLLEGE T319 Bur Block
PDT, INC.
R981 Cement Kit
In Commercial Distribution

  • 00813677024473 ()
R981

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe

PDT, Inc. - 00813677024992

Kit Includes: (T007B-F) B-Series FlipTop™ Cassette - Fixed Rack 7 (R006) 11-12 Amazing Gracey™ Extended Reach Mini (R007) 13-14 Amazing Gracey™ Extended Reach Mini (R064) Columbia 13-14 (R130S) Jack B. Nimble® (R138) Montana Jack® (R224) 23 Explorer-Williams O Probe (R245) Cone Socket Mirror Handle (T050) #5 Mirror (15/16")
PDT, INC.
R970 Just Be Nice Hygiene Kit with Cassette
In Commercial Distribution

  • 00813677024992 ()
R970

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle

PDT, Inc. - 00813677024831

Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R061 Barnhart 5-6 R080 Langer 3-4 R130S Jack B. Nimble® Slim R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R223 23 Explorer-12 Probe R245 Cone Socket Mirror Handle T043 Cotton Pliers T050 #5 Mirror (15/16”)
PDT, INC.
R913 PDT I Dream of Hygiene™ Kit
In Commercial Distribution

  • 00813677024831 ()
R913

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, reusable

PDT, Inc. - 00813677024862

Kit Includes: T009C-F C-Series FlipTop™ Cassette - Fixed Rack 9 R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R195 Probe 12 (3-6-9-12) R245 Cone Socket Mirror Handle T050 #5 Mirror (15/16")
PDT, INC.
R917 PDT Amazing Gracey™ Prophy Kit
In Commercial Distribution

  • 00813677024862 ()
R917

  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle

DataLINK DLK900 - 05060481691925

DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
DLK900
In Commercial Distribution

  • 05060481691925 ()
DataLINK DLK900 - plastic connectors

  • Biomechanical function analysis system, motion-tracking
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