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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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Haier - 06949573516317

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L959BP
In Commercial Distribution

  • 06949573516317 ()
DW-86L959BP

  • Ultralow-temperature laboratory freezer

Haier - 06949573516300

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L829BP
In Commercial Distribution

  • 06949573516300 ()
DW-86L829BP

  • Ultralow-temperature laboratory freezer

Haier - 06949573516003

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L828JA
In Commercial Distribution

  • 06949573516003 ()
DW-86L828JA

  • Ultralow-temperature laboratory freezer

Haier - 06949573515990

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L728J
In Commercial Distribution

  • 06949573515990 ()
DW-86L728J

  • Ultralow-temperature laboratory freezer

Haier - 06949573515792

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L338J
In Commercial Distribution

  • 06949573515792 ()
DW-86L338J

  • Ultralow-temperature laboratory freezer

Haier - 06949573514092

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L338JA
In Commercial Distribution

  • 06949573514092 ()
DW-86L338JA

  • Ultralow-temperature laboratory freezer

Haier - 06949573513958

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L578JA
In Commercial Distribution

  • 06949573513958 ()
DW-86L578JA

  • Ultralow-temperature laboratory freezer

Haier - 06949573513927

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L728JA
In Commercial Distribution

  • 06949573513927 ()
DW-86L728JA

  • Ultralow-temperature laboratory freezer

Haier - 06949573512999

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L490JA
In Commercial Distribution

  • 06949573512999 ()
DW-86L490JA

  • Ultralow-temperature laboratory freezer

Haier - 06949573512401

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86W420JA
In Commercial Distribution

  • 06949573512401 ()
DW-86W420JA

  • Ultralow-temperature laboratory freezer

Haier Biomedical - 06949573501092

Ultra low temperature freezer
Qingdao Haier Biomedical Co Ltd
DW-86L730BPT
In Commercial Distribution

  • 06949573501092 ()
DW-86L730BPT

  • Ultralow-temperature laboratory freezer

Bausch + Lomb - 00757770522699

CARTER CELL SWEEPER 90/90
Bausch & Lomb Incorporated
E0647
In Commercial Distribution

  • 00757770522699 ()
E0647

  • Ophthalmic surgical probe, reusable

OrthoPediatrics PediFoot Deformity Correction System - 00841132159170

90°-90° Cut Guide, Large
ORTHOPEDIATRICS CORP.
01-1007-0016
In Commercial Distribution

  • 00841132159170 ()
01-1007-0016

  • Osteotomy guide, reusable

OrthoPediatrics PediFoot Deformity Correction System - 00841132159156

90°-90° Cut Guide, Small
ORTHOPEDIATRICS CORP.
01-1007-0014
In Commercial Distribution

  • 00841132159156 ()
01-1007-0014

  • Osteotomy guide, reusable

OrthoPediatrics PediFoot Deformity Correction System - 00841132159163

90°-90° Cut Guide, Medium
ORTHOPEDIATRICS CORP.
01-1007-0015
In Commercial Distribution

  • 00841132159163 ()
01-1007-0015

  • Osteotomy guide, reusable

Horizon™ - 10816843024014

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") TWISTED LEADWIRE, COLOR GROUP 3
ROCHESTER ELECTRO-MEDICAL, INC.
S92090-PT3-20
Not in Commercial Distribution

  • 10816843023062 ()
  • 10816843024014 ()


  • Subdermal needle electrode

Horizon™ - 10816843024007

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") TWISTED LEADWIRE, COLOR GROUP 1
ROCHESTER ELECTRO-MEDICAL, INC.
S92090-P1-10
Not in Commercial Distribution

  • 10816843023055 ()
  • 10816843024007 ()


  • Subdermal needle electrode

Horizon™ - 10816843023970

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C
ROCHESTER ELECTRO-MEDICAL, INC.
S91090-C-20
Not in Commercial Distribution

  • 10816843023970 ()
  • 10816843022218 ()


  • Subdermal needle electrode

Horizon™ - 10816843023840

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 2.3 M (90") TWISTED LEADWIRE, COLOR GROUP 1
ROCHESTER ELECTRO-MEDICAL, INC.
S92690-PT1-20
Not in Commercial Distribution

  • 10816843023840 ()
  • 10816843023857 ()


  • Subdermal needle electrode

Horizon™ - 10816843023048

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") TWISTED LEADWIRE, COLOR GROUP 1
ROCHESTER ELECTRO-MEDICAL, INC.
S92090-P
Not in Commercial Distribution

  • 10816843023048 ()


  • Subdermal needle electrode

Horizon™ - 10816843022270

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C
ROCHESTER ELECTRO-MEDICAL, INC.
S91690-50/PK
Not in Commercial Distribution

  • 10816843022270 ()
  • 10816843022263 ()


  • Subdermal needle electrode

Horizon™ - 10816843022201

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C
ROCHESTER ELECTRO-MEDICAL, INC.
S91090-50
Not in Commercial Distribution

  • 10816843022201 ()
  • 10816843022195 ()


  • Subdermal needle electrode

Horizon™ - 10816843021556

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") PARALLEL LEADWIRE, COLOR GROUP 1
ROCHESTER ELECTRO-MEDICAL, INC.
S02244-90-I
Not in Commercial Distribution

  • 10816843021556 ()
  • 10816843021549 ()


  • Subdermal needle electrode

Diamatrix - 00813059016706

Chang Nucleus Hydrossector Cannula, 27 Gauge, 1.2mm flat Standard tip angled 90° with beveled opening, 16mm tip length
Diamatrix
C558-27.1.2
In Commercial Distribution

  • 00813059016706 ()
C558-27.1.2

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Diamatrix - 00813059015860

Chang Nucleus Hydrossector Cannula, 27 Gauge, 1.5mm flat Standard tip angled 90° with beveled opening, 16mm tip length
Diamatrix
C558-27.1.5
In Commercial Distribution

  • 00813059015860 ()
C558-27.1.5

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MM MARKED PAPER POINTS - 08806383567411

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383567411 ()
MP201-893

  • Endodontic paper point

MM MARKED GUTTA PERCHA POINTS - 08806383567169

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PROISO-.06 PLUS 90
In Commercial Distribution

  • 08806383567169 ()
ML159-815

  • Natural gutta-percha

MM MARKED PAPER POINTS - 08806383561020

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383561020 ()
CMP201-493

  • Endodontic paper point

MM MARKED GUTTA PERCHA POINTS - 08806383560795

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383560795 ()
CML101-493

  • Natural gutta-percha

MM MARKED GUTTA PERCHA POINTS - 08806383559751

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PROISO-.06 PLUS 90
In Commercial Distribution

  • 08806383559751 ()
CML159-S615

  • Natural gutta-percha

ABSORBENT PAPER POINTS - 08806383557962

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383557962 ()
201-S693

  • Endodontic paper point

GUTTA PERCHA POINTS - 08806383557832

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383557832 ()
101-S693

  • Natural gutta-percha

ABSORBENT PAPER POINTS - 08806383556446

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383556446 ()
C201-493

  • Endodontic paper point

GUTTA PERCHA POINTS - 08806383556217

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383556217 ()
C101-493

  • Natural gutta-percha

ABSORBENT PAPER POINTS - 08806383554619

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383554619 ()
C201-693

  • Endodontic paper point

GUTTA PERCHA POINTS - 08806383554381

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383554381 ()
C101-693

  • Natural gutta-percha

ABSORBENT PAPER POINTS - 08806383516785

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383516785 ()
256-493

  • Endodontic paper point

ABSORBENT PAPER POINTS - 08806383512770

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383512770 ()
201-683

  • Endodontic paper point

ABSORBENT PAPER POINTS - 08806383512329

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383512329 ()
201-593

  • Endodontic paper point

ABSORBENT PAPER POINTS - 08806383512282

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383512282 ()
201-583

  • Endodontic paper point

GUTTA PERCHA POINTS - 08806383509145

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383509145 ()
156-593

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383508605

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383508605 ()
156-493

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383508377

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383508377 ()
155-493

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383508018

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383508018 ()
153-693

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383502191

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383502191 ()
101-693

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383501682

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383501682 ()
101-583

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383501231

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383501231 ()
101-493

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383500753

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383500753 ()
101-193

  • Natural gutta-percha

ABSORBENT PAPER POINTS - 08806383517249

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383517249 ()
256-593

  • Endodontic paper point

ABSORBENT PAPER POINTS - 08806383512824

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383512824 ()
201-693

  • Endodontic paper point
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