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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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Sentient Manufacturing - 00860007603723

Laser Fiber Cannula 6" - 150 mm
Sentient Manufacturing, LLC
3041210
In Commercial Distribution

  • 00860007603723 ()


  • General/multiple surgical laser system beam guide, reusable

Sentient Manufacturing - 00860007603716

Laser Fiber Cannula 10" - 250 mm
Sentient Manufacturing, LLC
3041200
In Commercial Distribution

  • 00860007603716 ()


  • General/multiple surgical laser system beam guide, reusable

Sentient Manufacturing - 00860007603709

10 X Use Laser Fiber - 550 Micron
Sentient Manufacturing, LLC
3041100
In Commercial Distribution

  • 00860007603709 ()


  • General/multiple surgical laser system beam guide, reusable

InnoVoyce VYLO Eye Safety Filter Leica - 00860004755999

InnoVoyce VYLO Eye Safety Filter Leica
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755999 ()
ASY-300143

  • General/multiple surgical laser system beam guide, reusable

InnoVoyce LLC - 00860004755913

KTP Laser Fiber 600
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755913 ()
  • 10860004755903 ()

  • Outer Diameter: 600 Micrometer
KLF-001-600

  • General/multiple surgical laser system beam guide, single-use

InnoVoyce LLC - 00860004755906

KTP Laser Fiber 400
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755906 ()
  • 20860004755900 ()

  • Outer Diameter: 400 Micrometer
KLF-001-400

  • General/multiple surgical laser system beam guide, single-use

Delasco Electricator Reusable Patient Plate - 00609960000282

ELECTRICATOR PATIENT GROUNDING PLATE, EACH
DERMATOLOGIC LAB AND SUPPLY, INC.
26900
In Commercial Distribution

  • 00609960000282 ()
26900

  • Electrosurgical return electrode, reusable

Premier - D6919006540

GROUNDING PAD, UNDIVIDED - DISP 5PK
PREMIER DENTAL PRODUCTS COMPANY
9006540
In Commercial Distribution

  • D6919006540 ()


  • Electrosurgical return electrode, single-use, sterile

Premier - D6919006550

GROUNDING PAD - SPLIT, DISPOSABLE 5PK
PREMIER DENTAL PRODUCTS COMPANY
9006550
In Commercial Distribution

  • D6919006550 ()


  • Electrosurgical return electrode, single-use, sterile

Connection Cable Remote Control / RF-Generator - 04260166370539

No Description
Stockert GmbH
S7041
In Commercial Distribution

  • 04260166370539 ()


  • Electrical catheter connection cable, reusable

Extension Cable for Foot Pedal - 04260166370430

No Description
Stockert GmbH
M546354
In Commercial Distribution

  • 04260166370430 ()


  • Electrical catheter connection cable, reusable

EP/IO Box Connection Cable - 04260166370317

No Description
Stockert GmbH
S7031
In Commercial Distribution

  • 04260166370317 ()


  • Electrical catheter connection cable, reusable

ECG-Connection Cable with isolated Tips - 04260166370294

No Description
Stockert GmbH
S7015
In Commercial Distribution

  • 04260166370294 ()


  • Electrical catheter connection cable, reusable

Connection Cable Indifferent Patch-Electrode (3M) - 04260166370096

No Description
Stockert GmbH
S7008
In Commercial Distribution

  • 04260166370096 ()


  • Electrical catheter connection cable, reusable

Serial Computer Interface Cable - 04260166370058

No Description
Stockert GmbH
S7013
In Commercial Distribution

  • 04260166370058 ()


  • Electrical catheter connection cable, reusable

Laser Surgery Fibers and Probes - 04260155592317

HiFlex Fiber, 600 micrometers, Universal Centering
A.R.C. Laser GmbH
LL28068s
In Commercial Distribution

  • 04260155592348 ()
  • 04260155592317 ()
LL28068s

  • General/multiple surgical laser system beam guide, single-use

Laser Surgery Fibers and Probes - 04260155592225

HiFlex Fiber, 300 micrometer, Universal Centering
A.R.C. Laser GmbH
LL28062s
In Commercial Distribution

  • 04260155592256 ()
  • 04260155592225 ()
LL28062s

  • General/multiple surgical laser system beam guide, single-use

Laser Surgery Fibers and Probes - 04260155591976

HiFlex Fiber, 400 micrometer, Universal Centering
A.R.C. Laser GmbH
LL28066s
In Commercial Distribution

  • 04260155591983 ()
  • 04260155591976 ()
LL28066s

  • General/multiple surgical laser system beam guide, single-use

Laser Surgery Fibers and Probes - 04260155591501

Otology probe long universal centering
A.R.C. Laser GmbH
LL28058s
In Commercial Distribution

  • 04260155591914 ()
  • 04260155591501 ()
  • 04260155591709 ()
  • 04260155592805 ()
LL28058s

  • General/multiple surgical laser system beam guide, reusable

Laser Surgery Fibers and Probes - 04260155591488

Bare fiber 600 micrometer/400 micrometer
A.R.C. Laser GmbH
LL13034s
In Commercial Distribution

  • 04260155591891 ()
  • 04260155591488 ()
  • 04260155591686 ()
  • 04260155592843 ()
LL13034s

  • General/multiple surgical laser system beam guide, reusable

Laser Surgery Fibers and Probes - 04260155591464

Endo probe 25 gauge
A.R.C. Laser GmbH
LL13010s
In Commercial Distribution

  • 04260155591877 ()
  • 04260155591464 ()
  • 04260155591662 ()
  • 04260155592911 ()
LL13010s

  • General/multiple surgical laser system beam guide, reusable

Laser Surgery Fibers and Probes - 04260155591082

Bare Fiber 200µm
A.R.C. Laser GmbH
LL13003s
In Commercial Distribution

  • 4260155591808 ()
  • 04260155591082 ()
  • 04260155591594 ()
  • 04260155592829 ()
LL13003s

  • General/multiple surgical laser system beam guide, reusable

Laser Surgery Fibers and Probes - 04260155591044

Bare Fiber 600µm universal centering
A.R.C. Laser GmbH
LL28008s
In Commercial Distribution

  • 04260155591785 ()
  • 04260155591044 ()
  • 04260155591570 ()
  • 04260155592874 ()
LL28008s

  • General/multiple surgical laser system beam guide, reusable

Laser Surgery Fibers and Probes - 04260155590498

Endoprobe 21 gauge
A.R.C. Laser GmbH
LL13014s
In Commercial Distribution

  • 04260155591761 ()
  • 04260155590498 ()
  • 04260155591556 ()
  • 04260155592997 ()
LL13014s

  • General/multiple surgical laser system beam guide, reusable

Laser Surgery Fibers and Probes - 04260155590351

Endo Probe 23 Gauge
A.R.C. Laser GmbH
LL13006s
In Commercial Distribution

  • 04260155591747 ()
  • 04260155590351 ()
  • 04260155591532 ()
  • 04260155592942 ()
LL13006s

  • General/multiple surgical laser system beam guide, reusable

Sensifirm - bronze - 05060445341309

The Sensifirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US04SNS
In Commercial Distribution

  • 05060445341309 ()


  • Radio-frequency skin surface treatment system

Sensilift - 05060445341255

The Sensilift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US04SNS
In Commercial Distribution

  • 05060445341255 ()


  • Radio-frequency skin surface treatment system

sensiLift - 05060445341125

The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US01SNS
In Commercial Distribution

  • 05060445341125 ()


  • Radio-frequency skin surface treatment system

sensiFirm - 05060445341118

The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US01SNS
In Commercial Distribution

  • 05060445341118 ()


  • Radio-frequency skin surface treatment system

Axonics - 10810005340219

Stimulation Ground Cables
AXONICS MODULATION TECHNOLOGIES, INC.
9003
In Commercial Distribution

  • 10810005340219 ()
  • 00810005340212 ()
9003

  • Electrosurgical return electrode, single-use

L’DISQ® - 08800015900027

No Description
CG MedTech Co.,Ltd.
PD03
In Commercial Distribution

  • 08800015900027 ()


  • Electrosurgical return electrode, single-use, sterile

L’DISQ® - 08800015900010

No Description
CG MedTech Co.,Ltd.
PD01
In Commercial Distribution

  • 08800015900010 ()


  • Electrosurgical return electrode, single-use, sterile

L’DISQ® - 08800015900003

No Description
CG MedTech Co.,Ltd.
PD02
In Commercial Distribution

  • 08800015900003 ()


  • Electrosurgical return electrode, single-use, sterile

Valleylab - 10884524001067

REM Polyhesive (TM) Neonatal Patient Return Electrode
Covidien LP
E7512
In Commercial Distribution

  • 20884524001064 ()
  • 10884524001067 ()

  • Length: 9 Feet
  • Weight,1-6,Lbs;


  • Electrosurgical return electrode, single-use

Valleylab - 10884524001050

REM Polyhesive (TM) Infant Patient Return Electrode
Covidien LP
E7510-25DB
In Commercial Distribution

  • 20884524001057 ()
  • 10884524001050 ()

  • Length: 15 Feet
  • Weight,6-30,Lbs;


  • Electrosurgical return electrode, single-use

Valleylab - 10884524001043

REM Polyhesive (TM) Infant Patient Return Electrode
Covidien LP
E7510-25
In Commercial Distribution

  • 20884524001040 ()
  • 10884524001043 ()

  • Length: 9 Feet
  • Weght,6-30,Lbs;


  • Electrosurgical return electrode, single-use

Valleylab - 10884524001012

REM Polyhesive (TM) Adult Cordless Patient Return Electrode
Covidien LP
E7509B
In Commercial Distribution

  • 20884524001019 ()
  • 10884524001012 ()
  • 30884524001016 ()

  • Weight,Greater than 30,lbs;


  • Electrosurgical return electrode, single-use

Valleylab - 10884524000992

REM Polyhesive (TM) Adult Cordless Patient Return Electrode
Covidien LP
E7508
In Commercial Distribution

  • 20884524000999 ()
  • 10884524000992 ()

  • Weight, >30, Lbs;


  • Electrosurgical return electrode, single-use

Valleylab - 10884524000985

Non-REM Polyhesive Patient Return Electrode
Covidien LP
E7506
In Commercial Distribution

  • 20884524000982 ()
  • 10884524000985 ()

  • Length: 9 Feet


  • Electrosurgical return electrode, single-use

Valleylab - 10884524000602

REM Polyhesive Adult Patient Return Electrode
Covidien LP
E7507DB
In Commercial Distribution

  • 20884524000609 ()
  • 10884524000602 ()

  • Length: 15 Feet
  • Weight, >30, lbs;


  • Electrosurgical return electrode, single-use

Valleylab - 10884524000077

REM Polyhesive Adult Patient Return Electrode
Covidien LP
E7507
In Commercial Distribution

  • 20884524000074 ()
  • 10884524000077 ()

  • Length: 9 Feet
  • Weight, >30, lbs;


  • Electrosurgical return electrode, single-use

Sensimatic™ - M595D6340

Indifferent Plate for Sensimatic™ Electrosurge
PARKELL, INC.
D634
Not in Commercial Distribution

  • M595D6340 ()
D634

  • Electrosurgical return electrode, reusable

Sensimatic™ - M595D6010

New Indifferent Plate & Red Cable for Sensimatic™ 600SE (Complies with New FDA Lead Wire Regulations)
PARKELL, INC.
D601
Not in Commercial Distribution

  • M595D6010 ()
D601

  • Electrosurgical return electrode, reusable

Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable Tip - M47320489HP0

Ho:YAG OmniTip HP System, Sidefire, 6.5 cm
TRIMEDYNE, INC.
20489-HP
In Commercial Distribution

  • M47320489HP1 ()
  • M47320489HP0 ()
20489-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - 60° - M47320478HP0

Tip, Switchable, Omni HP System, 60 degree
TRIMEDYNE, INC.
20478-HP
In Commercial Distribution

  • M47320478HP1 ()
  • M47320478HP0 ()
20478-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® Reposable OmniTip™ Switchable Tip - 30° - M47320476MHP0

Multiuse Switchable Tip, Omni HP System, 30 degree
TRIMEDYNE, INC.
20476M-HP
In Commercial Distribution

  • M47320476MHP1 ()
  • M47320476MHP0 ()
20476M-HP

  • General/multiple surgical laser system beam guide, reusable

Trimedyne® OmniTip™ Switchable Tip - 30° - M47320476HP0

Tip, Switchable, Omni HP System, 30 degree
TRIMEDYNE, INC.
20476-HP
In Commercial Distribution

  • M47320476HP1 ()
  • M47320476HP0 ()
20476-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - 20° - M47320475HP0

Tip, Switchable, Omni HP System, 20 degree
TRIMEDYNE, INC.
20475-HP
In Commercial Distribution

  • M47320475HP1 ()
  • M47320475HP0 ()
20475-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - Straight - M47320474HP0

Tip, Switchable, Omni HP System, 0 degree
TRIMEDYNE, INC.
20474-HP
In Commercial Distribution

  • M47320474HP1 ()
  • M47320474HP0 ()
20474-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® Ho:YAG Omni™ Multiuse Handpiece With Fiber Assembly (SMA Connector) - M47320471HP0

Handpiece, Multiuse, HP System, SMA Connector
TRIMEDYNE, INC.
20471-HP
In Commercial Distribution

  • M47320471HP0 ()
20471-HP

  • General/multiple surgical laser system beam guide, reusable
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