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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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Legato® - 04250337103783

Legato® Hand Piece, monopolar
Joimax GmbH
JMPH352504
In Commercial Distribution

  • 04250337103783 ()


  • Electrosurgical system

Legato® - 04250337103745

Legato® Probe monopolar, Ball Tip
Joimax GmbH
JMPP27025
In Commercial Distribution

  • 04250337103752 ()
  • 04250337103745 ()


  • Electrosurgical system

Surgi-Max® Plus - 00846338010652

No Description
ELLIQUENCE, LLC
IEC4-SP
In Commercial Distribution

  • 00846338010652 ()


  • Electrosurgical system

Surgi-Max® - 00846338001803

No Description
ELLIQUENCE, LLC
IEC4-SM120
In Commercial Distribution

  • 00846338001803 ()


  • Electrosurgical system

Surgi-Max® Ultra - 00846338001643

No Description
ELLIQUENCE, LLC
IEC6-SU120
In Commercial Distribution

  • 00846338001643 ()


  • Electrosurgical system

Surgi-Max® Ultra - 00846338001438

No Description
ELLIQUENCE, LLC
IEC6-SU170
In Commercial Distribution

  • 00846338001438 ()


  • Electrosurgical system

Root ZX3 - 04548213056545

No Description
J.MORITA MFG.CORP.
RZX3 Type: HF
In Commercial Distribution

  • 04548213056545 ()


  • Electrosurgical system

GT9 Heavy Ball Electrode (5mm) - 04719873121342

No Description
BONART CO., LTD.
GT9
In Commercial Distribution

  • 04719873121342 ()


  • Electrosurgical system

GT8 Heavy Ball Electrode (2.38mm) - 04719873121335

No Description
BONART CO., LTD.
GT8
In Commercial Distribution

  • 04719873121335 ()


  • Electrosurgical system

GT5 Heavy Wire Electrode - 04719873121328

No Description
BONART CO., LTD.
GT5
In Commercial Distribution

  • 04719873121328 ()


  • Electrosurgical system

GT4 Fine Wire Electrode - 04719873121311

No Description
BONART CO., LTD.
GT4
In Commercial Distribution

  • 04719873121311 ()


  • Electrosurgical system

GT3 Large Loop Electrode - 04719873121304

No Description
BONART CO., LTD.
GT3
In Commercial Distribution

  • 04719873121304 ()


  • Electrosurgical system

GT2 Small Loop Electrode - 04719873121298

No Description
BONART CO., LTD.
GT2
In Commercial Distribution

  • 04719873121298 ()


  • Electrosurgical system

GT1 Blade Type Electrode - 04719873121281

No Description
BONART CO., LTD.
GT1
In Commercial Distribution

  • 04719873121281 ()


  • Electrosurgical system

ART GT E1 Electrode Set - 04719873121267

No Description
BONART CO., LTD.
TE0002-022RH
In Commercial Distribution

  • 04719873121267 ()


  • Electrosurgical system

E1 Indiference Plate - 04719873121250

No Description
BONART CO., LTD.
EU0004-182RH
In Commercial Distribution

  • 04719873121250 ()


  • Electrosurgical system

E1 Handpiece (S) - 04719873121243

No Description
BONART CO., LTD.
EU0016-052RH
In Commercial Distribution

  • 04719873121243 ()


  • Electrosurgical system

E1 Handpiece (L) - 04719873121236

No Description
BONART CO., LTD.
EU0016-002RH
In Commercial Distribution

  • 04719873121236 ()


  • Electrosurgical system

METAL GROUNDING PLATE & CORD - 04719873121229

No Description
BONART CO., LTD.
EU0004-142RH
In Commercial Distribution

  • 04719873121229 ()


  • Electrosurgical system

E1 INDIFFERENCE PLATE ∮ 6.3mm - 04719873121212

No Description
BONART CO., LTD.
EU0004-062RH
In Commercial Distribution

  • 04719873121212 ()


  • Electrosurgical system

T9 Heavy ball electrode - 04719873120529

No Description
BONART CO., LTD.
T9
In Commercial Distribution

  • 04719873120529 ()


  • Electrosurgical system

T7 Fine oval loop electrode - 04719873120512

No Description
BONART CO., LTD.
T7
In Commercial Distribution

  • 04719873120512 ()


  • Electrosurgical system

T5 Heavy wire electrode - 04719873120505

No Description
BONART CO., LTD.
T5
In Commercial Distribution

  • 04719873120505 ()


  • Electrosurgical system

T4 Fine wire electrode - 04719873120499

No Description
BONART CO., LTD.
T4
In Commercial Distribution

  • 04719873120499 ()


  • Electrosurgical system

T3 Large loop electrode - 04719873120482

No Description
BONART CO., LTD.
T3
In Commercial Distribution

  • 04719873120482 ()


  • Electrosurgical system

T2 Small loop electrode - 04719873120475

No Description
BONART CO., LTD.
T2
In Commercial Distribution

  • 04719873120475 ()


  • Electrosurgical system

T1 Diamond shaped electrode - 04719873120468

No Description
BONART CO., LTD.
T1
In Commercial Distribution

  • 04719873120468 ()


  • Electrosurgical system

E1 electrode set (7 tips) - 04719873120185

No Description
BONART CO., LTD.
73120185
In Commercial Distribution

  • 04719873120185 ()


  • Electrosurgical system

E1 Indifference plate - 04719873120178

No Description
BONART CO., LTD.
EU0004-002R
In Commercial Distribution

  • 04719873120178 ()


  • Electrosurgical system

E1 Hand Piece - 04719873120161

No Description
BONART CO., LTD.
73120161
In Commercial Distribution

  • 04719873120161 ()


  • Electrosurgical system

ELECTROSURGERY SYSTEM - 04719873120048

No Description
BONART CO., LTD.
ART-E1
In Commercial Distribution

  • 04719873120048 ()


  • Electrosurgical system

XTHERMA - 08809709380466

10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-H/P
In Commercial Distribution

  • 08809709380466 ()


  • Electrosurgical system

XTHERMA - 08809709380459

XTHERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-Body
In Commercial Distribution

  • 08809709380459 ()


  • Electrosurgical system

10THERMA - 08809709380343

10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
TMSY02
In Commercial Distribution

  • 08809709380343 ()


  • Electrosurgical system

10THERMA - 08809709380350

10THERMA Handpiece
TENTECH Inc.
TMHP02
In Commercial Distribution

  • 08809709380350 ()


  • Electrosurgical system

CELLINEW TIP - 08809502330385

No Description
VIOL Co.,Ltd.
CE25
In Commercial Distribution

  • 08809502330385 ()


  • Electrosurgical system

CELLINEW Handpiece - 08809502330361

No Description
VIOL Co.,Ltd.
CELLINEW Handpiece
In Commercial Distribution

  • 08809502330361 ()


  • Electrosurgical system

Foot switch - 08809502330187

No Description
VIOL Co.,Ltd.
F/S-B
In Commercial Distribution

  • 08809502330187 ()


  • Electrosurgical system

Handpiece - 08809502330170

No Description
VIOL Co.,Ltd.
P/B
In Commercial Distribution

  • 08809502330170 ()


  • Electrosurgical system

XA25 - 08809502330156

No Description
VIOL Co.,Ltd.
J25BS
In Commercial Distribution

  • 08809502330156 ()


  • Electrosurgical system
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