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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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ProFlex™ - 00816959020392

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020392 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020385

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020385 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020378

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020378 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020354

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 910 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020354 ()
R-LLF910-T, R-LLF1000-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020330

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 550 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020330 ()
R-LLF550-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020316

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 365 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020316 ()
R-LLF365-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020293

Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 273 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020293 ()
R-LLF273TG-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020286

Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020286 ()
S-LLF273TG-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020262

Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 200 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020262 ()
S-LLF200TG-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020828

No Description
INNOVAQUARTZ LLC
DSU273PT
In Commercial Distribution

  • 00816959020828 ()
DSU273PT

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020781

No Description
INNOVAQUARTZ LLC
TSU1000PF
In Commercial Distribution

  • 00816959020781 ()
TSU1000PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020767

No Description
INNOVAQUARTZ LLC
TSU365PF
In Commercial Distribution

  • 00816959020767 ()
TSU365PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020743

No Description
INNOVAQUARTZ LLC
TSU200PF
In Commercial Distribution

  • 00816959020743 ()
TSU200PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020736

No Description
INNOVAQUARTZ LLC
SU1000PF
In Commercial Distribution

  • 00816959020736 ()
SU1000PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020712

No Description
INNOVAQUARTZ LLC
SU365PF
In Commercial Distribution

  • 00816959020712 ()
SU365PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020699

No Description
INNOVAQUARTZ LLC
DSU273PF
In Commercial Distribution

  • 00816959020699 ()
DSU273PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020675

ProFlex® 200 Laser Lithotripsy Fiber Single-Use
INNOVAQUARTZ LLC
DSU200PF
In Commercial Distribution

  • 00816959020675 ()
DSU200PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020651

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 365 Laser Fiber var. Aurora™
In Commercial Distribution

  • 00816959020651 ()
R-LLF365AU, R-LLF365AU-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020644

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 365 Laser Fiber var. Aurora™
In Commercial Distribution

  • 00816959020644 ()
S-LLF365AU, S-LLF365AU-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020620

Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 200 Laser Lithotripsy Fiber var. ProTrac
In Commercial Distribution

  • 00816959020620 ()
S-LLF200TRC, S-LLF200TRC-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020613

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 910 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020613 ()
R-LLF910, R-LLF910-OCS, R-LLF1000, R-LLF1000-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020590

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 550 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020590 ()
R-LLF550, R-LLF550-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020569

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020569 ()
S-LLF365, S-LLF365-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020545

Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020545 ()
S-LLF273LT, S-LLF273TG, S-LLF273-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020521

Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 200 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020521 ()
S-LLF200LT, S-LLF200TG, S-LLF200-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020507

Maximum Power (J x PPS): 10W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 150 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020507 ()
S-LLF150LT

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020484

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020484 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020361

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020361 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020347

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 910 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020347 ()
S-LLF910-T, S-LLF1000-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020323

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 550 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020323 ()
S-LLF550-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020309

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020309 ()
S-LLF365-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020279

Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 200 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020279 ()
R-LLF200TG-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020255

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020255 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020248

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020248 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020231

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020231 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020224

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020224 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020217

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020217 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020200

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020200 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020194

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020194 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020187

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020187 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020170

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber var. SPY Trimedyne
In Commercial Distribution

  • 00816959020170 ()
S-LLF365SPY-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020163

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020163 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020156

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020156 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020149

Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber var. SPY Trimedyne
In Commercial Distribution

  • 00816959020149 ()
S-LLF273SPY-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020132

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020132 ()
S-LLF365SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020125

Maximum Power (J x PPS): 50W Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020125 ()
S-LLF273SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020118

Maximum Power (J x PPS): 30W Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 200 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020118 ()
S-LLF200SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020101

Maximum Power (J x PPS): 10W Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 150 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020101 ()
SLLF150SPY

  • General/multiple surgical laser system beam guide, reusable

NeuLight® - 00816901023976

No Description
Weinert Fiber Optics, Inc.
WF IR600/630ST-3/SM-F 1030X3S
In Commercial Distribution

  • 01816901023975 ()
  • 00816901023976 ()
  • 02816901023974 ()
098337

  • General/multiple surgical laser system beam guide, reusable

Arthrex® - 00888867062597

DISP SPLIT ADULT RETURN ELECTROD W/C
ARTHREX, INC.
AR-9610SGP
In Commercial Distribution

  • 00888867062597 ()
  • M150AR9610SGP1 ()
  • 10888867062594 ()
AR-9610SGP

  • Electrosurgical return electrode, single-use
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