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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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Up Rongeur, 4 x 10mm - 81195401219900

No Description
INTERVENTIONAL SPINE, INC
6190-02
Not in Commercial Distribution

  • 81195401219900 ()
6190-02

  • Orthopaedic joint/limb rongeur

Straight Rongeur, 4 x 10mm - 81195401218224

No Description
INTERVENTIONAL SPINE, INC
6190-01
Not in Commercial Distribution

  • 81195401218224 ()
6190-01

  • Orthopaedic joint/limb rongeur

TiLink-P Screw 12mm x 25mm - 00810131880842

No Description
SURGENTEC, LLC
SI-SGT-25
In Commercial Distribution

  • 00810131880842 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-P Screw 12mm x 30mm - 00810131880613

No Description
SURGENTEC, LLC
SI-SGT-30
In Commercial Distribution

  • 00810131880613 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 60mm x 10mm - 00810131880491

No Description
SURGENTEC, LLC
SI-L-60
In Commercial Distribution

  • 00810131880491 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 55mm x 10mm - 00810131880484

No Description
SURGENTEC, LLC
SI-L-55
In Commercial Distribution

  • 00810131880484 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 50mm x 10mm - 00810131880477

No Description
SURGENTEC, LLC
SI-L-50
In Commercial Distribution

  • 00810131880477 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 45mm x 10mm - 00810131880460

No Description
SURGENTEC, LLC
SI-L-45
In Commercial Distribution

  • 00810131880460 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 40mm x 10mm - 00810131880453

No Description
SURGENTEC, LLC
SI-L-40
In Commercial Distribution

  • 00810131880453 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 35mm x 10mm - 00810131880446

No Description
SURGENTEC, LLC
SI-L-35
In Commercial Distribution

  • 00810131880446 ()


  • Laparoscopic access cannula anchor, single-use

TiLink-L Implant 30mm x 10mm - 00810131880439

No Description
SURGENTEC, LLC
SI-L-30
In Commercial Distribution

  • 00810131880439 ()


  • Laparoscopic access cannula anchor, single-use

X°Port Lung Preservation System - 07540161670153

Lung Preservation System
Traferox Technologies Inc
909-0011
In Commercial Distribution

  • 07540161670153 ()


  • General-purpose donor-organ preservation/transport system

2.0MM X 150MM GUIDE WIRE - 00887868106316

No Description
Biomet Orthopedics, LLC
36590
In Commercial Distribution

  • 00887868106316 ()

  • 2.0MM X 150MM
36590

  • Orthopaedic bone wire

.062 X 8" GUIDE WIRE - 00887868106279

No Description
Biomet Orthopedics, LLC
24416
In Commercial Distribution

  • 00887868106279 ()

  • .062 X 8" GUIDE WIRE
24416

  • Fluted surgical drill bit, reusable

CALIBRATED DRILL 4.3MM X 333MM - 00887868100239

No Description
Biomet Orthopedics, LLC
29431
In Commercial Distribution

  • 00887868100239 ()
29431

  • Biopsy drill bit

RECON DRILL 6MM X 489MM - 00887868094330

No Description
Biomet Orthopedics, LLC
14-442023
In Commercial Distribution

  • 00887868094330 ()
14-442023

  • Cannulated surgical drill bit, single-use

5MM X 320MM DRILL BIT - 00887868093258

No Description
Biomet Orthopedics, LLC
14-440043
In Commercial Distribution

  • 00887868093258 ()
14-440043

  • Fluted surgical drill bit, single-use

7MM X 200MM CANULATED DRILL - 00887868093234

No Description
Biomet Orthopedics, LLC
14-440041
In Commercial Distribution

  • 00887868093234 ()
14-440041

  • Cannulated surgical drill bit, single-use

1.6MM X 80MM GUIDE WIRE - 00887868091742

No Description
Biomet Orthopedics, LLC
14-401441
In Commercial Distribution

  • 00887868091742 ()
14-401441

  • Orthopaedic bone wire

1.6MM X 150MM GUIDE WIRE - 00887868091629

No Description
Biomet Orthopedics, LLC
14-401440
In Commercial Distribution

  • 00887868091629 ()
14-401440

  • Orthopaedic bone wire

X FIX ANGULATING SCREW CLAMP - 00887868083631

No Description
Biomet Orthopedics, LLC
06259
In Commercial Distribution

  • 00887868083631 ()
06259

  • External orthopaedic fixation system, single-use

TRUWAVE X 3 (3 CC) - 07460691952829

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK1140
In Commercial Distribution

  • 57460691952824 ()
  • 07460691952829 ()

  • Total Volume: 3.0000 Milliliter
PXMK1140

  • Invasive-pressure external transducer, single-use

Quattro® X Suture Anchor - 00887868270970

No Description
CAYENNE MEDICAL, INC.
CM-9265BGS
In Commercial Distribution

CM-9265BGS

  • Tendon/ligament bone anchor, non-bioabsorbable

Quattro® X Suture Anchor - 00887868270963

No Description
CAYENNE MEDICAL, INC.
CM-9265BG
In Commercial Distribution

CM-9265BG

  • Tendon/ligament bone anchor, non-bioabsorbable

Quattro® X Suture Anchor - 00887868270956

No Description
CAYENNE MEDICAL, INC.
CM-9255BGS
In Commercial Distribution

CM-9255BGS

  • Tendon/ligament bone anchor, non-bioabsorbable

Quattro® X Suture Anchor - 00887868270949

No Description
CAYENNE MEDICAL, INC.
CM-9255BG
In Commercial Distribution

CM-9255BG

  • Tendon/ligament bone anchor, non-bioabsorbable

Quattro® X Suture Anchor - 00887868270291

No Description
CAYENNE MEDICAL, INC.
CM-9265
In Commercial Distribution



  • Tendon/ligament bone anchor, non-bioabsorbable

Quattro® X Suture Anchor - 00887868270277

No Description
CAYENNE MEDICAL, INC.
CM-9255
In Commercial Distribution



  • Tendon/ligament bone anchor, non-bioabsorbable

Dental Putty - 6 x 0.5cc - 00813909010663

Synthetic bone void filler for dental applications
NOVABONE PRODUCTS, LLC
NA0660
In Commercial Distribution

  • 00813909010663 ()
  • 00813909010458 ()

  • 0.5cc
NA0660

  • Dental bone matrix implant, synthetic

Dental Putty 2 x 1.5cc - 00813909010656

Synthetic bone void filler for dental applications
NOVABONE PRODUCTS, LLC
NA0622
In Commercial Distribution

  • 00813909010656 ()
  • 00813909010441 ()

  • 1.5cc
NA0622

  • Dental bone matrix implant, synthetic

BioPlug BioHorizons - 20mm x 10mm - 00813909010250

Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2200
In Commercial Distribution

  • 00813909010250 ()
  • 00813909010533 ()

  • Width: 10 Millimeter
  • Length: 20 Millimeter
BH2200

  • General oral wound dressing, animal-derived

Carbon-Rubber Electrodes (8" x 3") - B243PSRCR2102

No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSRCR2102 ()


  • Transcutaneous electrical stimulation electrode, single-use

SteriTec Steam Integrator X 2 - 00814434020196

No Description
STERITEC PRODUCT MFG. CO., INC.
CI 143
In Commercial Distribution

  • 20814434020190 ()
  • 10814434020193 ()
  • 00814434020196 ()
CI 143

  • Chemical/physical sterilization process indicator

8mm x 16mm Foam Sleeves - B354CCS8169

8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8169 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

8mm x 16mm Foam Sleeves - B354CCS8165

8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8165 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

8mm x 16mm Foam Sleeves - B354CCS8163

8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8163 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

8mm x 16mm Foam Sleeves - B354CCS8161

8mm x 16mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS816
In Commercial Distribution

  • B35400 ()
  • B354CCS8161 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

5mm x 10mm Foam Sleeves - B354CCS5109

5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5109 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

5mm x 10mm Foam Sleeves - B354CCS5105

5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5105 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

5mm x 10mm Foam Sleeves - B354CCS5103

5mm x 10mm Foam Sleeves
ORANGE SURGICAL INSTRUMENTS, LLC
CCS510
In Commercial Distribution

  • B35400 ()
  • B354CCS5103 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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