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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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Optilite - 00855430006302

1000 micron circular 90 degree internal reflection fiber assembly w/ gold cap
Convergent Laser Technologies
SMA6110A
In Commercial Distribution

  • 00855430006302 ()


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

Optilite - 00855430006296

1000 micron fiber assembly with hand piece, 15 degree curved probe&cone tip
Convergent Laser Technologies
SMA4215C
In Commercial Distribution

  • 00855430006296 ()


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

Optilite - 00855430006289

600 micron fiber assembly with flexible cooling sheath
Convergent Laser Technologies
SMA2060F
In Commercial Distribution

  • 00855430006289 ()


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

GREENLIGHT - 04055207018170

LASER WORKING ELEMENT PASSIVE 30° closed, round, distal sheath end slanted, compatible with inner sheath 8655.344, and telescopes Ø 4mm, bayonet-cap, reusable
Richard Wolf GmbH
8632225
Not in Commercial Distribution

  • 04055207018170 ()

  • Angle: 30 degree
8632.225

  • General/multiple surgical laser system beam guide, reusable

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
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