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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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OrthoFlex - 00190730002112

OrtFlx Com McLaughlin 018 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-764
In Commercial Distribution

  • 00190730002112 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002105

OrtFlx Com McLaughlin 018 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-763
In Commercial Distribution

  • 00190730002105 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001849

OrtFlx Com McLaughlin 018 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-712
In Commercial Distribution

  • 00190730001849 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001825

OrtFlx Com McLaughlin 018 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-711
In Commercial Distribution

  • 00190730001825 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001801

OrtFlx Com McLaughlin 018 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-702
In Commercial Distribution

  • 00190730001801 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001788

OrtFlx Com McLaughlin 018 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-701
In Commercial Distribution

  • 00190730001788 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000651

Avalon Com McLaughlin 022 LL4 Rx -12° Tor. +2° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-864
Not in Commercial Distribution

  • 00190730000651 ()


  • Orthodontic bracket, plastic, single-use

ACE - 00614950024148

PROBE UNIVERSITY OF NC COLOR CODED 1-12 MARKINGS
ACE SURGICAL SUPPLY CO., INC.
6301106
In Commercial Distribution

  • 00614950024148 ()
6301106

  • Periodontal probe, reusable

OC-Auto - 00816917024622

Personal Use Kit OC-Auto, for University of Cincinnati
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-UCINN
In Commercial Distribution

  • 00816917024622 ()


  • Faecal occult blood IVD, reagent

Integra® Miltex® - 10381780203407

Probe, University of Michigan 0, Single End, Round
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
017-44100
Not in Commercial Distribution

  • H834017441000 ()
  • 10381780203407 ()
017-44100

  • Periodontal probe, reusable

HELMUT ZEPF - EZPF24751113C0

CURETTE INSERT, M4X0,5MM UNIVERSITY OF COLUMBIA FIG. 13
Helmut Zepf Medizintechnik GmbH
24.751.113C
In Commercial Distribution

  • EZPF24751113C0 ()
24.751.113C

  • Periodontal curette

HELMUT ZEPF - EZPF24751114C0

CURETTE INSERT, M4X0,5MM UNIVERSITY OF COLUMBIA FIG. 14
Helmut Zepf Medizintechnik GmbH
24.751.114C
In Commercial Distribution

  • EZPF24751114C0 ()
24.751.114C

  • Periodontal curette

Aero-Med - 10885380207679

Kit Adult Blood Culture for Howard University Only
AERO-MED, LLC
CA61900
In Commercial Distribution

  • 50885380207677 ()
  • 10885380207679 ()
CA61900

  • Phlebotomy kit

Aero-Med - 10885380197499

Kit Urine Collection for University of Iowa Only
AERO-MED, LLC
CA53550
Not in Commercial Distribution

  • 50885380197497 ()
  • 10885380197499 ()
CA53550

  • Urine specimen collection kit IVD

Aero-Med - 10885380178252

Blood Collection Kit, Augusta University Medical Center Only
AERO-MED, LLC
CA21225
Not in Commercial Distribution

  • 50885380178250 ()
  • 10885380178252 ()
CA21225

  • Phlebotomy kit

Henry Schein - H65857029275

Tray Dry Scrub F/ University of Florida Health
HENRY SCHEIN, INC.
5702927
In Commercial Distribution

  • H65857029271 ()
  • H65857029275 ()
5702927

  • General surgical procedure kit, non-medicated, single-use

General Biopsy Tray - 00886333217397

Custom General Biopsy Tray for Emory University Hospital
ARGON MEDICAL DEVICES, INC.
CG00548
Not in Commercial Distribution

  • 20886333217391 ()
  • 00886333217397 ()
CG00548

  • Soft-tissue biopsy procedure kit, medicated

N/A - 00884908054033

ROBERT WOOD JOHNSON UNIVERSITY CUSTOM TRAY (WITHOUT CATHETER)
Medical Components, Inc.
TRAY #201
Not in Commercial Distribution

  • 50884908054038 ()
  • 00884908054033 ()


  • Cardiac/peripheral vascular guidewire, single-use

Aero-Med - 10885380174827

Blood Culture Collection Kit, Virginia Commonwealth University Only
AERO-MED, LLC
CA22750
In Commercial Distribution

  • 50885380174825 ()
  • 10885380174827 ()
CA22750

  • Phlebotomy kit

Xltek - 00382830063067

NeuroWorks/SleepWorks 9.3.1 Installation Media (US)
XLTEK
034878
In Commercial Distribution

  • 00382830063067 ()


  • Electroencephalograph
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