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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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Dynamic Tip™ - 08714729877486

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0042003440
In Commercial Distribution

  • 08714729877486 ()

  • 5 mm Length
  • 6 F Diameter
  • 2.00 mm Diameter


  • Intracardiac electrode

Dynamic Tip™ - 08714729877479

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0042001310
In Commercial Distribution

  • 08714729877479 ()

  • 10 mm Length
  • 2.00 mm Diameter
  • 6 F Diameter


  • Intracardiac electrode

VIRTUE RF - 08800017100821

ViruteRF (3 Handpiece)
shenb Co., Ltd.
VirtueRF
In Commercial Distribution

  • 08800017100821 ()


  • Radio-frequency skin surface treatment system

Sterile Micro Needle Cartridge - 08800017100784

Blister Pack
shenb Co., Ltd.
Exact RF TIP II
In Commercial Distribution

  • 08800017100784 ()
  • 08800017100791 ()
  • 08800017100814 ()


  • Radio-frequency skin surface treatment system

Sterile Micro Needle Cartridge - 08800017100753

Blister Pack
shenb Co., Ltd.
Exact RF TIP
In Commercial Distribution

  • 08800017100753 ()
  • 08800017100760 ()
  • 08800017100777 ()


  • Radio-frequency skin surface treatment system

Virtue RF Microneedle Cartridge - 08800017100722

No Description
shenb Co., Ltd.
SmartRF 36PIN TIP
In Commercial Distribution

  • 08800017100722 ()
  • 08800017100739 ()


  • Radio-frequency skin surface treatment system

Virtue RF - 08800017100715

No Description
shenb Co., Ltd.
Virtue RF
In Commercial Distribution

  • 08800017100715 ()


  • Radio-frequency skin surface treatment system

Sterile Micro Needle Cartridge - 08800017100678

Blister Pack
shenb Co., Ltd.
Deep RF 12PIN TIP
In Commercial Distribution

  • 08800017100678 ()
  • 08800017100685 ()
  • 08800017100692 ()


  • Radio-frequency skin surface treatment system

Sterile Micro Needle Cartridge - 08800017100647

Blister Pack
shenb Co., Ltd.
Deep RF 36PIN TIP
In Commercial Distribution

  • 08800017100647 ()
  • 08800017100654 ()
  • 08800017100661 ()


  • Radio-frequency skin surface treatment system

Sterile Micro Needle Cartridge - 08800017100616

Blister Pack
shenb Co., Ltd.
Smart RF 36PIN TIP II
In Commercial Distribution

  • 08800017100616 ()
  • 08800017100623 ()
  • 08800017100630 ()


  • Radio-frequency skin surface treatment system

Sterile Micro Needle Cartridge - 08800017100579

Blister Pack
shenb Co., Ltd.
Smart RF 36PIN TIP
In Commercial Distribution

  • 08800017100579 ()
  • 08800017100586 ()
  • 08800017100593 ()


  • Radio-frequency skin surface treatment system

VIVACE Electrosurgical System - 08800017100463

No Description
shenb Co., Ltd.
VIVACE
In Commercial Distribution

  • 08800017100463 ()


  • Radio-frequency skin surface treatment system

VirtueRF - 08800017100456

No Description
shenb Co., Ltd.
VirtueRF
In Commercial Distribution

  • 08800017100456 ()


  • Radio-frequency skin surface treatment system

VIVACE Electrosurgical System - 08800017100326

No Description
shenb Co., Ltd.
VIVACE
In Commercial Distribution

  • 08800017100326 ()


  • Radio-frequency skin surface treatment system

VIVACE Microneedle Cartridge - 08800017100234

No Description
shenb Co., Ltd.
SH-TIP
In Commercial Distribution

  • 08800017100234 ()
  • 08800017100340 ()
  • 08800017100357 ()
  • 08800017100364 ()


  • Radio-frequency skin surface treatment system

OWL - 00825114000490

OWL GD-PAD PATIENT RETURN ELECTRODE, NON-CORDED
Diros Technology Inc
D7506NC
In Commercial Distribution

  • 00825114000490 ()
  • 00825114008434 ()
D7506NC

  • Electrosurgical return electrode, single-use

OWL - 00825114000483

OWL GD-PAD PATIENT RETURN ELECTRODE, CORDED
Diros Technology Inc
D7506
In Commercial Distribution

  • 00825114000483 ()
  • 00825114008427 ()
D7506

  • Electrosurgical return electrode, single-use

Bovie - 00821925008458

Blade Electrode Non-Stick (10/PK)
Gyrus ACMI, LLC
568605
In Commercial Distribution

  • 00821925008458 ()


  • Electrosurgical return electrode, single-use

Bovie - 00821925008083

Extended Blade Electrode 6” (15.24 cm) Non-Stick (10/PK)
Gyrus ACMI, LLC
568604
In Commercial Distribution

  • 00821925008083 ()


  • Electrosurgical return electrode, single-use

Bovie - 00821925008076

Disposable Sterile Non-Stick Blade Electrode (10/PK)
Gyrus ACMI, LLC
568601
In Commercial Distribution

  • 00821925008076 ()


  • Electrosurgical return electrode, single-use

Olympus - 00821925045750

TFL Fiber Stripper 940 Micron Non-Sterile, Single Use Soltive
Gyrus ACMI, LLC
TFL-AFS940-NS
In Commercial Distribution

  • 00821925045750 ()


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

Olympus - 00821925045743

TFL Fiber Stripper 550 Micron Non-Sterile, Single Use Soltive
Gyrus ACMI, LLC
TFL-AFS550-NS
In Commercial Distribution

  • 00821925045743 ()


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

Olympus - 00821925045736

TFL Fiber Stripper 365 Micron Non-Sterile, Single Use Soltive
Gyrus ACMI, LLC
TFL-AFS365-NS
In Commercial Distribution

  • 00821925045736 ()


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

Olympus - 00821925045729

TFL Fiber Stripper 200 Micron Non-Sterile, Single Use Soltive
Gyrus ACMI, LLC
TFL-AFS200-NS
In Commercial Distribution

  • 00821925045729 ()


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

Olympus - 00821925045712

TFL Fiber Stripper 150 Micron Non-Sterile, Single Use Soltive
Gyrus ACMI, LLC
TFL-AFS150-NS
In Commercial Distribution

  • 00821925045712 ()


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

Olympus - 00821925045705

TFL Fiber Cleaver Non-Sterile, Single Use Soltive (5/PK)
Gyrus ACMI, LLC
TFL-AFC-NS
In Commercial Distribution

  • 00821925045699 ()
  • 00821925045705 ()


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

Olympus - 00821925045590

Soltive 940 Micron reusable fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX940RE
In Commercial Distribution

  • 00821925045583 ()
  • 00821925045590 ()


  • General/multiple surgical laser system beam guide, reusable

Olympus - 00821925045576

Soltive 550 Micron reusable fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX550RE
In Commercial Distribution

  • 00821925045569 ()
  • 00821925045576 ()


  • General/multiple surgical laser system beam guide, reusable

Olympus - 00821925045552

Soltive 365 Micron reusable fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX365RE
In Commercial Distribution

  • 00821925045545 ()
  • 00821925045552 ()


  • General/multiple surgical laser system beam guide, reusable

Olympus - 00821925045538

Soltive 200 Micron reusable fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX200RE
In Commercial Distribution

  • 00821925045521 ()
  • 00821925045538 ()


  • General/multiple surgical laser system beam guide, reusable

Olympus - 00821925045514

Soltive 150 Micron reusable fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX150RE
In Commercial Distribution

  • 00821925045507 ()
  • 00821925045514 ()


  • General/multiple surgical laser system beam guide, reusable

Olympus - 00821925045491

Soltive 940 Micron single use fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX940SE
In Commercial Distribution

  • 00821925045484 ()
  • 00821925045491 ()


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

Olympus - 00821925045477

Soltive 550 Micron single use fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX550SE
In Commercial Distribution

  • 00821925045460 ()
  • 00821925045477 ()


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

Olympus - 00821925045453

Soltive 365 Micron single use fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX365SE
In Commercial Distribution

  • 00821925045446 ()
  • 00821925045453 ()


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

Olympus - 00821925045415

Soltive 200 Micron single use ball tip fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX200BSE
In Commercial Distribution

  • 00821925045408 ()
  • 00821925045415 ()


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

Olympus - 00821925045392

Soltive 150 Micron single use fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX150SE
In Commercial Distribution

  • 00821925045385 ()
  • 00821925045392 ()


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

Olympus - 00821925045378

Soltive 150 Micron single use ball tip fiber 2.0 (5/PK)
Gyrus ACMI, LLC
TFL-FBX150BSE
In Commercial Distribution

  • 00821925045361 ()
  • 00821925045378 ()


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

SOLTIVE - 00821925044104

SOLTIVE SuperPulsed Laser Fiber 940 Micron (5/PK)
Gyrus ACMI, LLC
TFL-FBX940R
In Commercial Distribution

  • 00821925044098 ()
  • 00821925044104 ()


  • General/multiple surgical laser system beam guide, reusable

SOLTIVE - 00821925044081

SOLTIVE SuperPulsed Laser Fiber 940 Micron (5/PK)
Gyrus ACMI, LLC
TFL-FBX940S
In Commercial Distribution

  • 00821925044074 ()
  • 00821925044081 ()


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

SOLTIVE - 00821925044043

SOLTIVE SuperPulsed Laser Fiber 550 Micron (5/PK)
Gyrus ACMI, LLC
TFL-FBX550S
In Commercial Distribution

  • 00821925044036 ()
  • 00821925044043 ()


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