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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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Bovie - 00821925008076

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

  • 00821925008076 ()


  • 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

100 Watt Holmium Side Fire Fiber - M473SF6000

100 Watt Holmium Side Fire Fiber
TRIMEDYNE, INC.
SF-600
In Commercial Distribution

  • M473SF6000 ()
SF-600

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

Trimedyne® FlexMax® 550 µm Single Use Fiber (SMA Connector) - M473S550SMA0

Fiber, Bare, 550um, Single Use, SMA Connector
TRIMEDYNE, INC.
S550SMA
In Commercial Distribution

  • M473S550SMA1 ()
  • M473S550SMA0 ()
S550SMA

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

Trimedyne® FlexMax® 550 µm Single Use Holmium Fiber - M473S5500

Fiber, Bare, 550um, Single Use, TMED Connector
TRIMEDYNE, INC.
S550
In Commercial Distribution

  • M473S55001 ()
  • M473S5500 ()
S550

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

Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector) - M473S365SMA0

Fiber, Bare, 365um, Single Use, SMA Connector
TRIMEDYNE, INC.
S365SMA
In Commercial Distribution

  • M473S365SMA1 ()
  • M473S365SMA0 ()
S365SMA

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

Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber - M473S3650

Fiber, Bare, 365um, Single Use, TMED Connector
TRIMEDYNE, INC.
S365
In Commercial Distribution

  • M473S3651 ()
  • M473S3650 ()
S365

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

Trimedyne® FlexMax® 272 µm Single Use Holmium Fiber (SMA Connector) - M473S272SMA0

Fiber, Bare, 272um, Single Use, SMA Connector
TRIMEDYNE, INC.
S272SMA
In Commercial Distribution

  • M473S272SMA1 ()
  • M473S272SMA0 ()
S272SMA

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

Trimedyne® FlexMax® 272 µm Single Use Holmium Bare Fiber - M473S2720

Fiber, Bare, 272um, Single Use, TMED Connector
TRIMEDYNE, INC.
S272
In Commercial Distribution

  • M473S2721 ()
  • M473S2720 ()
S272

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