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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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Hermetic™ Hermetic Plus External CSF Drainage System
Integra Lifesciences Corporation
SP0204
In Commercial Distribution

  • 10381780071983 ()
  • M269SP02041 ()
SP0204

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Integra® External CSF Drainage System Replacement Bags
Integra Lifesciences Corporation
INS8700
In Commercial Distribution

  • 30381780071017 ()
  • 10381780071013 ()
  • M269INS87001 ()

  • 700 ml
INS-8700

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Koala® Intrauterine Pressure Catheter with external balloon
CLINICAL INNOVATIONS, LLC
IPC-5000E
In Commercial Distribution

  • 20814247020172 ()
  • 10814247020175 ()
  • 00814247020178 ()


  • Intrapartum pressure monitoring catheter
External Hex Implant Driver, Multi-Unit Abutment, Ratchet Style
Implant Logistics, Inc.
DEH-0910-32
In Commercial Distribution

  • D762DEH0910320 ()


  • Surgical screwdriver, reusable
External Handpiece Sterile Single-Use, Blister Packaged, CO2RE Intima
Candela Corporation
AS95201
In Commercial Distribution

  • 00817495025063 ()


  • Dermatological laser beam guiding handpiece
Attune MAKE TO ORDER CLASSIC EXTERNAL ROTATION BODY
DEPUY ORTHOPAEDICS, INC.
2999-65-820
In Commercial Distribution

  • 10603295454441 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Oculocam digital camera kit (eyepiece and external mount).
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8100DC-Kit
In Commercial Distribution

  • B1778100DCKIT0 ()


  • Surgical camera holder
Max-550 MaxBlend External Medical Oxygen Sensor Taiwan Labeled
MAXTEC, LLC
Max-550
In Commercial Distribution

  • 00817770025641 ()
R140P02-101

  • Respiratory oxygen sensor
Soft-Form™ Thermo Plastic External Nasal Splint, Large
INVOTEC INTERNATIONAL, INC.
20-10131
In Commercial Distribution

  • 10818501022615 ()
  • 00818501022618 ()
20-10131

  • External nasal splint
Soft-Form™ Thermo Plastic External Nasal Splints, Regular
INVOTEC INTERNATIONAL, INC.
20-10111
In Commercial Distribution

  • 10818501022592 ()
  • 00818501022595 ()
20-10111

  • External nasal splint
Soft-Form™ Thermo Plastic External Nasal Splint, Large
INVOTEC INTERNATIONAL, INC.
20-10130
In Commercial Distribution

  • 10818501022462 ()
  • 00818501022465 ()
20-10130

  • External nasal splint
Soft-Form™ Thermo Plastic External Nasal Splint, Regular
INVOTEC INTERNATIONAL, INC.
20-10110
In Commercial Distribution

  • 10818501022448 ()
  • 00818501022441 ()
20-10110

  • External nasal splint
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.2
In Commercial Distribution

  • B501THINKQA0200020 ()


  • Radiation therapy software
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.1
In Commercial Distribution

  • B501THINKQA0200010 ()
TK2010, TK2020

  • Radiation therapy software
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.0
In Commercial Distribution

  • B501THINKQA0200000 ()
TK2010, TK2020

  • Radiation therapy software
PROFIX MIS 5-IN-1 STANDARD EXTERNAL ROT GDE NEUT
Smith & Nephew, Inc.
71513388
Not in Commercial Distribution

  • 03596010534200 ()
71513388

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROFIX MIS 5-IN-1 STANDARD EXTERNAL ROT GDE RIGHT
Smith & Nephew, Inc.
71513378
Not in Commercial Distribution

  • 03596010534118 ()
71513378

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROFIX MIS 5-IN-1 STANDARD EXTERNAL ROT GDE LEFT
Smith & Nephew, Inc.
71513368
Not in Commercial Distribution

  • 03596010534026 ()
71513368

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Combined System for Internal and External Sinus Lift
Hager & Meisinger Gesellschaft mit beschränkter Haftung
BLIPL
In Commercial Distribution

  • E0HM79BLIPL1 ()
BLIPL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
NPr Ab Ti Biomet 3i External Hex 3.4
Nobel Biocare AB
23198
Not in Commercial Distribution

  • 07332747102161 ()
23198

  • Dental implant suprastructure, permanent, preformed
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