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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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Delfin2 - D742DELF2040

Accessory, Cannula
INTRA-LOCK INTERNATIONAL, INC.
DELF2-04
In Commercial Distribution

  • D742DELF2040 ()
DELF2-04

  • Dental power tool system handpiece, line-powered

Delfin2 - D742DELF2030

Accessory, Memory Card
INTRA-LOCK INTERNATIONAL, INC.
DELF2-03
In Commercial Distribution

  • D742DELF2030 ()
DELF2-03

  • Dental power tool system handpiece, line-powered

Delfin2 - D742DELF2020

Accessory, Pump Irrigation Tubing, 10 Pack (Single Use)
INTRA-LOCK INTERNATIONAL, INC.
DELF2-02
In Commercial Distribution

  • D742DELF2020 ()
DELF2-02

  • Dental power tool system handpiece, line-powered

Delfin - D742DELF20

Delfin Surgical Motor and Contra-Angle 20:1 without DC
INTRA-LOCK INTERNATIONAL, INC.
Delf2
In Commercial Distribution

  • D742DELF20 ()
DELF2

  • Dental power tool system handpiece, line-powered

Delfin1 - D742DELF1070

Delf1 Irrigation Tubing 1-Way Single Use (10 Pack)
INTRA-LOCK INTERNATIONAL, INC.
DELF1-07
In Commercial Distribution

  • D742DELF1070 ()
DELF1-07

  • Dental power tool system handpiece, line-powered

Delfin1 - D742DELF1010

20:1 Reduction Contra-Angle Handpiece
INTRA-LOCK INTERNATIONAL, INC.
DELF1-01
In Commercial Distribution

  • D742DELF1010 ()
DELF1-01

  • Dental power tool system handpiece, line-powered

Delfin1 - D742DELF10

Delfin Surgical Motor and Contra-Angle 20:1
INTRA-LOCK INTERNATIONAL, INC.
DELF1
In Commercial Distribution

  • D742DELF10 ()
DELF1

  • Dental power tool system handpiece, line-powered

Delfin - D742CA200

Delfin Contra-Angle 20:1
INTRA-LOCK INTERNATIONAL, INC.
CA20
In Commercial Distribution

  • D742CA200 ()
CA20

  • Dental power tool system handpiece, line-powered

DYONICS - 00885554033502

DYONICS HD SAGITTAL SW W/KEY SML BD HNPC
Smith & Nephew, Inc.
72204119
In Commercial Distribution

  • 00885554033502 ()
72204119

  • Surgical power tool system handpiece, sawing, line-powered

DYONICS - 00885554033496

DYONICS KEYLESS SAGITTAL SW SML BT HNDPC
Smith & Nephew, Inc.
72204118
In Commercial Distribution

  • 00885554033496 ()
72204118

  • Surgical power tool system handpiece, sawing, line-powered

DYONICS - 00885554033489

DYONICS SAGITTAL SAW W/KEY SML BAT HNDPC
Smith & Nephew, Inc.
72204117
In Commercial Distribution

  • 00885554033489 ()
72204117

  • Surgical power tool system handpiece, sawing, line-powered

Micro compass saw MSS 5000 - ENOU5040MMT0

Micro compass saw MSS 5000
Nouvag AG
5040MMT
In Commercial Distribution

  • ENOU5040MMT0 ()


  • Surgical power tool system handpiece, sawing, line-powered

SURGmatic S15 L Pro - EKAV101440000

The SURGmatic S15 L Pro handpiece is intended for: • Oral, jaw and facial surgery • Tooth extraction procedures • Root resection • Osteotomy • Removal of carious material • Tooth, cavity and crown preparations • Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and / or oral surgery.
KaVo Dental GmbH
1.014.4000
In Commercial Distribution

  • EKAV101440000 ()
S15 L Pro

  • Dental power tool system handpiece, line-powered

SURGmatic Head S201 XL Pro - EKAV101386620

No Description
KaVo Dental GmbH
1.013.8662
In Commercial Distribution

  • EKAV101386620 ()
Head S201 XL Pro

  • Dental power tool system handpiece, line-powered

SURGmatic Head S201 L Pro - EKAV101386480

No Description
KaVo Dental GmbH
1.013.8648
In Commercial Distribution

  • EKAV101386480 ()
Head S201 L Pro

  • Dental power tool system handpiece, line-powered

Bio-Medicus® - 00613994622518

CANN CB96345-029 BIO-MED 29FR
MEDTRONIC, INC.
CB96345-029
Not in Commercial Distribution

  • 00613994622518 ()

  • Catheter Gauge: 29.0 French
  • Length: 50.0 Centimeter


  • Cardiopulmonary bypass cannula, femoral

MedGyn Laminaria - M803021026

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 6 with buttons
In Commercial Distribution

  • M803021026 ()
021026

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021025

dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5 with button
In Commercial Distribution

  • M803021025 ()
021025

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021024

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 4 with buttons
In Commercial Distribution

  • M803021024 ()
021024

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021023

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 3 with button
In Commercial Distribution

  • M803021023 ()
021023

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021022

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 2 with button
In Commercial Distribution

  • M803021022 ()
021022

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021018

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 8 long
In Commercial Distribution

  • M803021018 ()
021018

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021016

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 6 long
In Commercial Distribution

  • M803021016 ()
021016

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021015

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5 long
In Commercial Distribution

  • M803021015 ()
021015

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021014

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 4 long
In Commercial Distribution

  • M803021014 ()
021014

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021010

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 10 Extra Jumbo
In Commercial Distribution

  • M803021010 ()
021010

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021008

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 8
In Commercial Distribution

  • M803021008 ()
021008

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021006

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 6
In Commercial Distribution

  • M803021006 ()
021006

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021005

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5
In Commercial Distribution

  • M803021005 ()
021005

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021004

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 4
In Commercial Distribution

  • M803021004 ()
021004

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021003

Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 3
In Commercial Distribution

  • M803021003 ()
021003

  • Hygroscopic cervical dilator

MedGyn Laminaria - M803021002

dilator of the uterine cervix
MEDGYN PRODUCTS, INC.
size 2
In Commercial Distribution

  • M803021002 ()
021002

  • Hygroscopic cervical dilator

Trackit Battery Box - 05060275450370

No Description
LIFELINES LIMITED
PP3-S
In Commercial Distribution

  • 05060275450370 ()
1140

  • Electroencephalographic ambulatory recorder

Trackit Battery Box - 05060275450363

No Description
LIFELINES LIMITED
LI
In Commercial Distribution

  • 05060275450363 ()
1112

  • Electroencephalographic ambulatory recorder

Trackit Battery Box - 05060275450356

No Description
LIFELINES LIMITED
PP3
In Commercial Distribution

  • 05060275450356 ()
1111

  • Electroencephalographic ambulatory recorder

Trackit PCU - 05060275450349

No Description
LIFELINES LIMITED
Sleep Clickon PCU +SAO2
In Commercial Distribution

  • 05060275450349 ()
1220

  • Electroencephalographic ambulatory recorder

Trackit PCU - 05060275450332

No Description
LIFELINES LIMITED
Short Clickon PCU
In Commercial Distribution

  • 05060275450332 ()
1181

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450325

No Description
LIFELINES LIMITED
Trackit 20/4/B Kit
In Commercial Distribution

  • 05060275450325 ()
2120B/BT

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450318

No Description
LIFELINES LIMITED
Trackit 20/4 Kit
In Commercial Distribution

  • 05060275450318 ()
2120B

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450301

No Description
LIFELINES LIMITED
Trackit 18/8/B Kit
In Commercial Distribution

  • 05060275450301 ()
2121 B/BT

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450295

No Description
LIFELINES LIMITED
Trackit 18/8 Kit
In Commercial Distribution

  • 05060275450295 ()
2121B

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450288

No Description
LIFELINES LIMITED
Trackit 32/0/B Kit
In Commercial Distribution

  • 05060275450288 ()
2122B/BT

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450271

No Description
LIFELINES LIMITED
Trackit 32/0 Kit
In Commercial Distribution

  • 05060275450271 ()
2122B

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450264

No Description
LIFELINES LIMITED
Trackit 24/0/B Kit
In Commercial Distribution

  • 05060275450264 ()
2123B/BT

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450257

No Description
LIFELINES LIMITED
Trackit 24/0 Kit
In Commercial Distribution

  • 05060275450257 ()
2123B

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450240

No Description
LIFELINES LIMITED
Trackit 12/0/B Kit
In Commercial Distribution

  • 05060275450240 ()
2124B/BT

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450233

No Description
LIFELINES LIMITED
Trackit 12/0 Kit
In Commercial Distribution

  • 05060275450233 ()
2124B

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450226

No Description
LIFELINES LIMITED
Trackit 24/8/B Kit
In Commercial Distribution

  • 05060275450226 ()
2125B/BT

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450219

No Description
LIFELINES LIMITED
Trackit 24/8 Kit
In Commercial Distribution

  • 05060275450219 ()
2125B

  • Electroencephalographic ambulatory recorder

Trackit - 05060275450202

No Description
LIFELINES LIMITED
Trackit 3 BT 12/0/B
In Commercial Distribution

  • 05060275450202 ()
1174

  • Electroencephalographic ambulatory recorder
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