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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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MedDrain 10 Fr Closed Wound Drain - Round 88 Eyes, Coated
ARMM INC.
222010C
In Commercial Distribution

  • 10850082007698 ()
  • 00850082007691 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 7 Fr Closed Wound Drain - Round 88 Eyes, Coated
ARMM INC.
222070C
In Commercial Distribution

  • 10850082007681 ()
  • 00850082007684 ()


  • Closed-wound drain, non-bioabsorbable
Beds LTC Accessories Product Description P703 Length Extension 88",1ea
Drive Devilbiss Healthcare
P703LE
In Commercial Distribution

  • 00822383979458 ()


  • Basic electric home bed
  • Electrical assistive bed
Lower Extremity Drape 114 in x 88 in 126 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09157G-S
In Commercial Distribution

  • 40612479230277 ()
  • 10612479230269 ()


  • Patient surgical drape, single-use
Low Air Loss Mattress System, 88" x 36" x 10"
KAP MEDICAL
K-3oemMS88
In Commercial Distribution

  • 00817012020915 ()
K-3oemMS88

  • Low-air-loss bed
Symmetry® Clamp, Towel, 3 1/2 in, 88 mm
SYMMETRY SURGICAL INC.
225
In Commercial Distribution

  • 00887482059814 ()

  • Length: 3.5 Inch
225

  • Towel clamp, reusable
88" Y-Type Blood Set w/170 Micron Filter, Rotating Luer
ICU MEDICAL, INC.
B3177
In Commercial Distribution

  • 10887709005256 ()
  • 00887709005259 ()


  • Basic intravenous administration set, noninvasive
PEDIATRIC CRANIOTOMY DRAPE W/MICROBAN & PER.POU 88 X 128, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426091978 ()
  • 00748426091973 ()


  • Patient surgical drape, single-use
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
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
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
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
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
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
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
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
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
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
No Description
Dalian Rongbang Medical Healthy Devices Co., Ltd.
NA
In Commercial Distribution

  • 26973069980010 ()
  • 16973069980013 ()


  • Tongue depressor, surgical
No Description
Dalian Rongbang Medical Healthy Devices Co., Ltd.
NA
In Commercial Distribution

  • 06973069980016 ()


  • Tongue depressor, surgical
Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security screw (EVO)
WALDEMAR LINK GmbH & Co. KG
15-0037/27
In Commercial Distribution

  • 04026575274772 ()


  • Rotating hinged total knee prosthesis
Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
99-0090/27
In Commercial Distribution

  • 04026575306800 ()


  • Femoral stem prosthesis trial
Femoral stem prosthesis trial - General Instrument
WALDEMAR LINK GmbH & Co. KG
99-0984/27
In Commercial Distribution

  • 04026575409730 ()


  • Femoral stem prosthesis trial
Glenoid orthopaedic reamer - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
645-001/27
In Commercial Distribution

  • 04026575439614 ()


  • Glenoid orthopaedic reamer
Femoral segment, uncemented, CoCrMo, Ti6Al4V, L-shaped for rotating hinge and pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-2710/27
In Commercial Distribution

  • 04026575184200 ()


  • Knee arthroplasty wedge
ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
POLYMER TECHNOLOGY SYSTEMS, INC.
860
Not in Commercial Distribution

  • 00381930860019 ()
  • 10381930860016 ()
860

  • Glucose/ketone/lipid profile IVD, calibrator
Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383553810 ()
C101-S693

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

  • 08806383552738 ()
171-298

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

  • 08806383548502 ()
ML159-S615

  • Natural gutta-percha
"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

  • 08806383551502 ()
C201-S693

  • Endodontic paper point
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