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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ExFeel External Ø4.8/ L=13/ Non-Hex/ Transfer/ Small
Megagen Implant Co. Ltd
SEIN400
In Commercial Distribution

  • 08806388235537 ()
SEIN400

  • Dental implant suprastructure, permanent, preformed
ExFeel External Ø4.8/ L=13/ Hex/ Transfer/ Small
Megagen Implant Co. Ltd
SEIH400
In Commercial Distribution

  • 08806388235520 ()
SEIH400T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=4/ P=8/ Non-Hex
Megagen Implant Co. Ltd
RSCN748
In Commercial Distribution

  • 08806388233199 ()
RSCN748T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=3/ P=8/ Non-Hex
Megagen Implant Co. Ltd
RSCN738
In Commercial Distribution

  • 08806388233175 ()
RSCN738T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=2/ P=8/ Non-Hex
Megagen Implant Co. Ltd
RSCN728
In Commercial Distribution

  • 08806388233151 ()
RSCN728T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=1/ P=8/ Non-Hex
Megagen Implant Co. Ltd
RSCN718
In Commercial Distribution

  • 08806388233137 ()
RSCN718T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=4/ P=8/ Hex
Megagen Implant Co. Ltd
RSCH748
In Commercial Distribution

  • 08806388233113 ()
RSCH748T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=3/ P=8/ Hex
Megagen Implant Co. Ltd
RSCH738
In Commercial Distribution

  • 08806388233090 ()
RSCH738T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=2/ P=8/ Hex
Megagen Implant Co. Ltd
RSCH728
In Commercial Distribution

  • 08806388233076 ()
RSCH728T

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø7/ C=1/ P=8/ Hex
Megagen Implant Co. Ltd
RSCH718
In Commercial Distribution

  • 08806388233069 ()
RSCH718T

  • Dental implant suprastructure, permanent, preformed
ExFeel External Ø4.8/ L=13/ Non-Hex/ Transfer/ Regular
Megagen Implant Co. Ltd
REIN500
In Commercial Distribution

  • 08806388232567 ()
REIN500

  • Dental implant suprastructure, permanent, preformed
ExFeel External Ø4.8/ L=13/ Hex/ Transfer/ Regular
Megagen Implant Co. Ltd
REIH500
In Commercial Distribution

  • 08806388232543 ()
REIH500T

  • Dental implant suprastructure, permanent, preformed
5.5mm Straight Rod 450mm Ti Alloy external hex
CTL Medical Corporation
25-2201-450
In Commercial Distribution

  • 00841732149892 ()


  • Bone-screw internal spinal fixation system rod
5.5mm Straight Rod 350mm Ti Alloy external hex
CTL Medical Corporation
25-2201-350
In Commercial Distribution

  • 00841732149885 ()


  • Bone-screw internal spinal fixation system rod
5.5mm Straight Rod 250mm Ti Alloy external hex
CTL Medical Corporation
25-2201-250
In Commercial Distribution

  • 00841732149878 ()


  • Spinal bone screw, non-bioabsorbable
5.5mm Straight Rod 150mm Ti Alloy external hex
CTL Medical Corporation
25-2201-150
In Commercial Distribution

  • 00841732149861 ()


  • Spinal bone screw, non-bioabsorbable
5.5mm Straight Rod 600mm Ti Alloy external hex
CTL Medical Corporation
25-2201-600
In Commercial Distribution

  • 00841732150874 ()


  • Bone-screw internal spinal fixation system rod
5.5mm Straight Rod 450mm Ti Alloy external hex
CTL Medical Corporation
25-2200-450
In Commercial Distribution

  • 00841732150867 ()


  • Bone-screw internal spinal fixation system rod
LARGE EXTERNAL FIXATOR GRAPHIC CASE LIFT-OUT TRAY ASSEMBLY
Synthes GmbH
690.315.60
In Commercial Distribution

  • H679690315600 ()
  • 10886982252173 ()
69031560

  • Surgical instrument/implant rack
PACE 203 External Dual-Chamber Pacemaker (with bipolar terminals)
Osypka Medical GmbH
PACE 203
In Commercial Distribution

  • 04260451441067 ()
2003

  • External pacemaker, epicardial pacing
PACE 101 External Single-Chamber Pacemaker (with bipolar terminals)
Osypka Medical GmbH
PACE 101
In Commercial Distribution

  • 04260451441050 ()
2004

  • External pacemaker, epicardial pacing
PACE 203 External Dual-Chamber Pacemaker (with clamping terminals)
Osypka Medical GmbH
PACE 203
In Commercial Distribution

  • 04260451441029 ()
2002

  • External pacemaker, epicardial pacing
PACE 101 External Single-Chamber Pacemaker (with clamping terminals)
Osypka Medical GmbH
PACE 101
In Commercial Distribution

  • 04260451441012 ()
2001

  • External pacemaker, epicardial pacing
A box of 10 CYP2C19 External Control Kits.
Spartan Bioscience Inc
01004880-ABC (10)
In Commercial Distribution

  • 00628055420095 ()
01004880-ABC (10)

  • Nucleic acid amplification mastermix kit IVD
Oculocam digital camera kit (eyepiece and external mount).
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8100DC-Kit
In Commercial Distribution

  • B1778100DCKIT0 ()


  • Surgical camera holder
PROFIX I.F EXTERNAL ROTATION PADDLE 3 DEGREE RT
Smith & Nephew, Inc.
71512423
Not in Commercial Distribution

  • 03596010475602 ()
71512423

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROFIX I.F EXTERNAL ROTATION PADDLE 3 DEGREE LT
Smith & Nephew, Inc.
71512422
Not in Commercial Distribution

  • 03596010475596 ()
71512422

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Koala® Intrauterine Pressure Catheter with external balloon
CLINICAL INNOVATIONS, LLC
IPC-5000E
In Commercial Distribution

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


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

  • D762DEH0910320 ()


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

  • 00817770025641 ()
R140P02-101

  • Respiratory oxygen sensor
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
NPr Ab Ti Biomet 3i External Hex 3.4
Nobel Biocare AB
23198
Not in Commercial Distribution

  • 07332747102161 ()
23198

  • Dental implant suprastructure, permanent, preformed
NPr Ab Ti Biomet 3i External Hex 5.0
Nobel Biocare AB
23199
Not in Commercial Distribution

  • 07332747102154 ()
23199

  • Dental implant suprastructure, permanent, preformed
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
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