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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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Gold Abutment - 08806388232468

ExFeel External Non-Hex
Megagen Implant Co. Ltd
REGC100
In Commercial Distribution

  • 08806388232468 ()
REGC100T

  • Dental implant suprastructure, permanent, preformed

Cover Screw - 08806388231430

ExFeel External M2
Megagen Implant Co. Ltd
RDC100
In Commercial Distribution

  • 08806388231430 ()
RDC100

  • Dental implant suprastructure, permanent, preformed

Open End Wrench - 08806388228133

Rescue Ex External
Megagen Implant Co. Ltd
MOW400
In Commercial Distribution

  • 08806388228133 ()
MOW400

  • Surgical screwdriver, reusable

Abutment Screw - 08806388225392

Rescue External M2.5
Megagen Implant Co. Ltd
LWCS250
In Commercial Distribution

  • 08806388225392 ()
LWCS250

  • Dental implant suprastructure, permanent, preformed

Cover Screw - 08806388225217

Rescue External Ø5
Megagen Implant Co. Ltd
LWC100
In Commercial Distribution

  • 08806388225217 ()
LWC100

  • Dental implant suprastructure, permanent, preformed

CORTRAK* 2 Enteral Access System - 00350770456690

External Power Supply
Avanos Medical, Inc.
20-0975
In Commercial Distribution

  • 00350770456690 ()
20-0975

  • Subcutaneous tunneller, single-use

CORTRAK* 2 Enteral Access System - 00350770456607

External Power Cord
Avanos Medical, Inc.
20-0968
In Commercial Distribution

  • 00350770456607 ()
20-0968

  • Subcutaneous tunneller, single-use

SURGICAL INSTRUMENTATION - 07290110722524

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
RTD-XR ø 5.20mm
In Commercial Distribution

  • 07290110722524 ()
RTD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722517

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
WTD-XR ø 4.30mm
In Commercial Distribution

  • 07290110722517 ()
WTD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722500

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
GTD-XR ø 3.65mm
In Commercial Distribution

  • 07290110722500 ()
GTD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722494

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
STD-XR ø 3.20mm
In Commercial Distribution

  • 07290110722494 ()
STD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722487

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
NTD-XR ø 2.80mm
In Commercial Distribution

  • 07290110722487 ()
NTD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722470

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
FSD-XR ø 2.50mm
In Commercial Distribution

  • 07290110722470 ()
FSD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722463

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
XTD-XR ø 2.20mm
In Commercial Distribution

  • 07290110722463 ()
XTD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722456

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
PD-XR ø 2.0mm
In Commercial Distribution

  • 07290110722456 ()
PD-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722449

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
RB-XR
In Commercial Distribution

  • 07290110722449 ()
RB-XR

  • Dental implant/prosthesis surgical procedure kit

SURGICAL INSTRUMENTATION - 07290110722432

EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
CSD-XR
In Commercial Distribution

  • 07290110722432 ()
CSD-XR

  • Dental implant/prosthesis surgical procedure kit

Precision Spectra ™ - M365SC51320

External Trial Stimulator
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5132
In Commercial Distribution

  • M365SC51320 ()
sc-5132

  • Analgesic spinal cord electrical stimulation system

Precision ™ - M365SC51100

External Trial Stimulator
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5110
In Commercial Distribution

  • M365SC51100 ()
SC-5110

  • Analgesic spinal cord electrical stimulation system

ANALOG - 07290113352889

Analog External Stainless
DENTIN IMPLANTS TECHNOLOGIES LTD
AES-1241
In Commercial Distribution

  • 07290113352889 ()


  • Dental implant analog

Essential External Wrench - 00766054002185

EDS External Wrench
ESSENTIAL DENTAL SYSTEMS, INC.
193-00
In Commercial Distribution

  • 00766054002185 ()
193-00

  • Pin/post dental drill bit

Sonoma Orthopedic Products, Inc - 00816988011248

Solid External Sheath
ARTHREX, INC.
IN0165
Not in Commercial Distribution

  • 00816988011248 ()
IN0165

  • Surgical drill guide, reusable

DeRoyal - 00749756142717

Otitis External Wick
DEROYAL INDUSTRIES, INC.
34-402
In Commercial Distribution

  • 50749756142712 ()
  • 00749756142717 ()
34-402

  • Ear wick, non-biodegradable

U2™ Knee - 04719872174950

External rotation guide driver
UNITED ORTHOPEDIC CORP.
9303-5023
In Commercial Distribution

  • 04719872174950 ()
9303-5023

  • Surgical instrument handle, non-torque-limiting

Medline Industries, Inc. - 10193489516814

EXTERNAL FIXATOR REMOVAL PACK
MEDLINE INDUSTRIES, INC.
DYNDA2370
In Commercial Distribution

  • 10193489516814 ()
DYNDA2370

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

CARDINAL HEALTH - 10888439163735

EXTERNAL FIXATOR REMOVAL PACK
Cardinal Health 200, LLC
SOP42EFUK1
In Commercial Distribution

  • 50888439163733 ()
  • 10888439163735 ()
SOP42EFUK1

  • Orthopaedic surgical procedure kit, medicated

Medtronic Reusable Instruments - 00643169106468

ASM EX1111148 5.5 EXTERNAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1111148
In Commercial Distribution

  • 00643169106468 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

T2 - 04546540682246

External Compression Device GTN
Stryker GmbH
1806-1601
In Commercial Distribution

  • 04546540682246 ()
1806-1601

  • General internal orthopaedic fixation system implantation kit

DERMACLOSE - 00844735006223

Continuous External Tissue Expander
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM204020-K
In Commercial Distribution

  • 00844735006223 ()
580120000011

  • Skin-closing tension device

DERMACLOSE - 00844735006216

Continuous External Tissue Expander
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM204010-K
In Commercial Distribution

  • 00844735006216 ()
580110000011

  • Skin-closing tension device

NA - 00613994647832

MOTOR 560A EXTERNAL DRIVE
MEDTRONIC, INC.
560A
In Commercial Distribution

  • 00613994647832 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

5391 - 00643169382978

Single Chamber External Pacemaker
Oscor Inc.
5391
Not in Commercial Distribution

  • 00643169382978 ()
5391

  • External pacemaker, epicardial pacing

HLS Noetos - 05056139214813

Tibial external alignment rod
CORIN LTD
MDE007
In Commercial Distribution

  • 05056139214813 ()
MDE007

  • Orthopaedic prosthesis implantation positioning instrument, reusable

TITAN IMPLANTS, INC. - 00842448112125

Fixture Mount External Hex
TITAN IMPLANT INC
T-FMEH-4
In Commercial Distribution

  • 00842448112125 ()


  • Dental implant system

Trilogy - 00606959005396

Trilogy External Battery Cable
Respironics, Inc.
00
In Commercial Distribution

  • 00606959005396 ()
1047295

  • Portable electric ventilator

TITAN IMPLANTS, INC. - 00842448110374

4.1mm External Hex Analog
TITAN IMPLANT INC
T-4IAT
In Commercial Distribution

  • 00842448110374 ()


  • Dental implant analog

Sensor - 00606959051812

External Flow Sensor Cable
Respironics, Inc.
External Flow Sensor Cable
In Commercial Distribution

  • 00606959051812 ()
1134592

  • Portable electric ventilator

NA - 00884838003361

External Paddles with PCI
Philips Medical Systems Hsg
861269
In Commercial Distribution

  • 00884838003361 ()
M4746A

  • Internal defibrillation electrode, adult, reusable

VOCSN External Bacterial Filter - 00855573007013

VOCSN External Bacterial Filter
VENTEC LIFE SYSTEMS, INC.
PRT-00790-001
In Commercial Distribution

  • 00855573007198 ()
  • 00855573007013 ()
PRT-00790-003

  • In-exsufflator
  • Portable electric ventilator

RejuvaHeart - 00868331000409

External Counter Pulsation Device
NORTH AMERICAN ECP INC.
NCP-2
In Commercial Distribution

  • 00868331000409 ()

  • Height: 29 Inch
  • Length: 80 Inch
  • Width: 35.25 Inch
  • Width: 30 Inch
  • Height: 66.5 Inch
  • Length: 18.5 Inch
No

  • External counterpulsation system, stationary

eCoin External Controller Kit - 00860007896972

eCoin External Controller Kit
Valencia Technologies Corporation
1011-5436
In Commercial Distribution

  • 00860007896972 ()
1011-5436

  • Tibial nerve implantable incontinence-control electrical stimulation system

eCoin External Controller Kit - 00860007896910

eCoin External Controller Kit
Valencia Technologies Corporation
1011-1752
In Commercial Distribution

  • 00860007896910 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system

Luke Replaceable Part - 00859503006145

ASSY, EXTERNAL BATTERY CHARGER
MOBIUS BIONICS LLC
LU-20272-001
In Commercial Distribution

  • 00859503006145 ()


  • Myoelectric hand prosthesis

NA - 10885862252838

TEMPLATE, EXTERNAL TRACKER, FIXATOR
Exactech, Inc.
521-40-14
In Commercial Distribution

  • 10885862252838 ()
521-40-14

  • Orthopaedic stereotactic surgery system

NA - 10886705005123

External Sterilization Case Lid
Medos International Sàrl
215459
In Commercial Distribution

  • 10886705005123 ()
215459

  • Instrument tray, reusable

NA - 04046964958212

EXTERNAL BOLUS BUTTON ASSET
B. BRAUN MEDICAL INC.
8710988-99
In Commercial Distribution

  • 04046964958212 ()
8710988-99

  • Bedside syringe pump

Microstream - 10884521548404

MICROSTREAM Capnostream35 External Charger
ORIDION MEDICAL 1987 LTD.
PM35CHG
Not in Commercial Distribution

  • 10884521548404 ()


  • Noninvasive device battery charger

PUMA-G System™ - 10850026037132

External Magnet in Case
Coaptech, Inc.
0010323
In Commercial Distribution

  • 10850026037132 ()
  • 00850026037135 ()
  • 00850026037142 ()
0010366

  • Ultrasound-guided gastrostomy system magnet

PUMA-G System™ - 10860312001532

External Magnet in Case
Coaptech, Inc.
0010080
In Commercial Distribution

  • 00860312001542 ()
  • 10860312001532 ()
  • 00860312001535 ()
0010090

  • Ultrasound-guided gastrostomy system magnet

ACS - 00191072099471

ROBOTIC KNEE EXTERNAL- NONSTERILE
AMERICAN CONTRACT SYSTEMS, INC.
MDRE31B
In Commercial Distribution

  • 00191072099471 ()


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