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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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FlexiMarc™ - 00853730006008

Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-0.9-2-10-GG-18-20
In Commercial Distribution

  • 00853730006008 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable

Freemie - 00851690007936

12 In Short Tubing
DAO HEALTH
FG125
In Commercial Distribution

  • 10851690007933 ()
  • 00851690007936 ()


  • Breast pump support kit, reusable

CardioMEMS™ - 05414734509565

0.018 in / 260 cm
CARDIOMEMS, INC.
Guidewire
In Commercial Distribution

  • 15414734509562 ()
  • 05414734509565 ()

  • Outer Diameter: 0.018 Inch
  • Length: 260 Centimeter
CM2010

  • Cardiac/peripheral vascular guidewire, single-use

YUKON OCT Spinal System - 10888857341470

In Situ Bender (Left)
K2M, INC.
7601-90052
In Commercial Distribution

  • 10888857341470 ()
7601-90052

  • Orthopaedic prosthesis implantation positioning instrument, reusable

YUKON OCT Spinal System - 10888857341463

In Situ Bender (Right)
K2M, INC.
7601-90051
In Commercial Distribution

  • 10888857341463 ()
7601-90051

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medline Industries, Inc. - 10889942831951

IN OFFICE PROCEDURE PACK
MEDLINE INDUSTRIES, INC.
DYNJ58154
In Commercial Distribution

  • 10889942831951 ()
  • 40889942831952 ()
DYNJ58154

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

Medline Industries, Inc. - 10195327001384

IN ROOM KIT 2
MEDLINE INDUSTRIES, INC.
DYKM1555B
In Commercial Distribution

  • 40195327001385 ()
  • 10195327001384 ()
DYKM1555B

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

Medline Industries, Inc. - 10889942180219

CONNECTOR 5 IN 1
MEDLINE INDUSTRIES, INC.
DYNJZ25911
In Commercial Distribution

  • 40889942180210 ()
  • 10889942180219 ()
DYNJZ25911

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

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007299

2 IN RND PIN
COMPASS HEALTH BRANDS CORP.
300-168
Not in Commercial Distribution

  • 00850958007299 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007282

3 IN RND SNAP
COMPASS HEALTH BRANDS CORP.
300-167
Not in Commercial Distribution

  • 00850958007282 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007275

2 IN OVAL PIN
COMPASS HEALTH BRANDS CORP.
300-166
Not in Commercial Distribution

  • 00850958007275 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007251

3 IN RND PIN
COMPASS HEALTH BRANDS CORP.
300-163
Not in Commercial Distribution

  • 00850958007251 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007237

1 IN RND PIN
COMPASS HEALTH BRANDS CORP.
300-157
Not in Commercial Distribution

  • 00850958007237 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007213

4 IN OVAL PIN
COMPASS HEALTH BRANDS CORP.
300-160
Not in Commercial Distribution

  • 00850958007213 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007206

4 IN OVAL SNAP
COMPASS HEALTH BRANDS CORP.
300-159
Not in Commercial Distribution

  • 00850958007206 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007190

1 IN RND SNAP
COMPASS HEALTH BRANDS CORP.
300-158
Not in Commercial Distribution

  • 00850958007190 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007183

2 IN ROUND SNAP
COMPASS HEALTH BRANDS CORP.
300-155
Not in Commercial Distribution

  • 00850958007183 ()


  • Transcutaneous electrical stimulation electrode, single-use

LSI Silver Self Adhesive, Disposable Electrodes - 00850958007176

2 IN RND PIN
COMPASS HEALTH BRANDS CORP.
300-156
Not in Commercial Distribution

  • 00850958007176 ()


  • Transcutaneous electrical stimulation electrode, single-use

Medline Industries, Inc. - 10193489566765

IN ROOM KIT 2
MEDLINE INDUSTRIES, INC.
DYKM1555A
In Commercial Distribution

  • 10193489566765 ()
DYKM1555A

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

Ventlab - 10889483080085

Collapsible Spacer in Box
VENTLAB, LLC
br200-w
In Commercial Distribution

  • 20889483080082 ()
  • 10889483080085 ()

  • Outer Diameter: 22 Millimeter


  • Atomizer, non-ventilatory

Orfit Industries - 05420028717660

Central Panel in HPL
Orfit Industries NV
35781-N1/2
In Commercial Distribution

  • 05420028717660 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028709887

Block 40mm in CFL
Orfit Industries NV
35706
In Commercial Distribution

  • 05420028709887 ()


  • DNA-based tissue typing IVD, reagent

Nexxis OR - 05415334037687

MNA-440 ENC SDI IN
Barco NV
MNA-440
In Commercial Distribution

  • 05415334037687 ()
k9303301D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037632

MNA-420 ENC HDMI IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037632 ()
k9303320D

  • Operating room audiovisual data/device management system

EVEREST Spinal System - 10888857273153

Goniometer In Situ Telescoping
K2M, INC.
2901-90186
In Commercial Distribution

  • 10888857273153 ()
2901-90186

  • General-purpose calliper, metallic

MESA Small Stature Spinal System - 10888857186446

In Situ Bender (Left)
K2M, INC.
K2-30-2017-01
In Commercial Distribution

  • 10888857186446 ()
K2-30-2017-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA Small Stature Spinal System - 10888857186439

In Situ Bender (Right)
K2M, INC.
K2-30-2016-01
In Commercial Distribution

  • 10888857186439 ()
K2-30-2016-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242357

In Situ Bender (Right)
K2M, INC.
K2-11-2083-01
In Commercial Distribution

  • 10888857242357 ()
K2-11-2083-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242203

In Situ Bender (Left)
K2M, INC.
K2-11-2040-01
In Commercial Distribution

  • 10888857242203 ()
K2-11-2040-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Sonoma - 10889981086893

All In One Guide
Seaspine Orthopedics Corporation
92-0141
In Commercial Distribution

  • 10889981086893 ()
92-0141

  • Surgical drill guide, reusable

Millennium - 00190776170226

ZISPER Meatus Clamp In .
Avalign Technologies, Inc.
1-124570
In Commercial Distribution

  • 00190776170226 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Millennium - 00190776170141

Hibbs Gouge . in GN
Avalign Technologies, Inc.
1-704245
In Commercial Distribution

  • 00190776170141 ()


  • Surgical gouge

Spiration Valve System - 00896506002309

Valve in Cartridge, 9mm
Gyrus Acmi, Llc
SVS-V9-00
In Commercial Distribution

  • 00896506002309 ()

  • Outer Diameter: 9 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002293

Valve in Cartridge, 6mm
Gyrus Acmi, Llc
SVS-V6-00
In Commercial Distribution

  • 00896506002293 ()

  • Outer Diameter: 6 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002286

Valve in Cartridge , 5mm
Gyrus Acmi, Llc
SVS-V5-00
In Commercial Distribution

  • 00896506002286 ()

  • Outer Diameter: 5 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002279

Valve in Cartridge, 7mm
Gyrus Acmi, Llc
SVS-V7-00
In Commercial Distribution

  • 00896506002279 ()

  • Outer Diameter: 7 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002200

Valve in Cartridge, 9mm
Gyrus Acmi, Llc
HUS-V9
In Commercial Distribution

  • 00896506002200 ()

  • Outer Diameter: 9 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002101

Valve in Cartridge, 7mm
Gyrus Acmi, Llc
HUS-V7
In Commercial Distribution

  • 00896506002101 ()

  • Outer Diameter: 7 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002095

Valve in Cartridge, 6mm
Gyrus Acmi, Llc
HUS-V6
In Commercial Distribution

  • 00896506002095 ()

  • Outer Diameter: 6 Millimeter


  • Endobronchial valve

Spiration Valve System - 00896506002088

Valve in Cartridge , 5mm
Gyrus Acmi, Llc
HUS-V5
In Commercial Distribution

  • 00896506002088 ()

  • Outer Diameter: 5 Millimeter


  • Endobronchial valve

Sure-Lok Extended Tab Pedicle Screw System - 00840019922517

Sleeve, All in One
PRECISION SPINE, INC.
48-9001
In Commercial Distribution

  • 00840019922517 ()
48-9001

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Midline Cortical Screw System - 00840019927727

In Situ Bender, Right
PRECISION SPINE, INC.
59-RD-0051
In Commercial Distribution

  • 00840019927727 ()
59-RD-0051

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform MC Screw System - 00840019927710

In Situ Bender, Left
PRECISION SPINE, INC.
59-RD-0050
In Commercial Distribution

  • 00840019927710 ()
59-RD-0050

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Sklar - 10649111458163

BACKHAUS-ROEDER TOWEL CLP5.25 IN
SKLAR CORPORATION
47-2940
In Commercial Distribution

  • 10649111458163 ()


  • Towel clamp, reusable

Sklar - 10649111454424

HUSTINX PERINEAL SPREADER8.75 IN
SKLAR CORPORATION
60-7430
In Commercial Distribution

  • 10649111454424 ()


  • Self-retaining surgical retractor, reusable

Zimmer Tourniquet - 00816317023317

Zimmer Tourniquet 18 in.
RENU MEDICAL, INC
RM-60707500300
In Commercial Distribution

  • 10816317023314 ()
  • 00816317023317 ()


  • Tourniquet cuff, reprocessed

M.U.S.T. Rod-to-Rod Connector - 07630030861345

In Line Connector Unsterile
Medacta International SA
03.54.800
In Commercial Distribution

  • 07630030861345 ()


  • Bone-screw internal spinal fixation system connector

Spine Instruments - 07630971208841

In situ rod cutter
Medacta International SA
03.75.10.0054
In Commercial Distribution

  • 07630971208841 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630971287242

In Line Connector - Trial
Medacta International SA
03.51.10.1200
In Commercial Distribution

  • 07630971287242 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Centurion - 10653160330936

EXT SET 63 IN
CENTURION MEDICAL PRODUCTS CORPORATION
MC330667
In Commercial Distribution

  • 00653160330939 ()
  • 10653160330936 ()
MC330667

  • Intravenous line stopcock
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