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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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TheraStrand® with I-Seed - 00813787020310

TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215iN
In Commercial Distribution

  • 00813787020310 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with I-Seed - 00813787020303

TheraStrand® TSL in TPSII Single – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215i
In Commercial Distribution

  • 00813787020303 ()


  • Manual brachytherapy source, permanent implant

FlexGuard Fiber with Sheath - B14527750300U1FS0

300 micrometer FlexGuard Fiber with Sheath
OPTICAL INTEGRITY INC
27750300U1FS
Not in Commercial Distribution

  • B14527750300U13FS1 ()
  • B14527750300U1FS0 ()

  • Outer Diameter: 300 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable

FlexGuard Fiber with Sheath - B14527750272U1FS0

272 micrometer FlexGuard Fiber with Sheath
OPTICAL INTEGRITY INC
27750272U1FS
Not in Commercial Distribution

  • B14527750272U13FS1 ()
  • B14527750272U1FS0 ()

  • Outer Diameter: 272 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable

FlexGuard Fiber with Sheath - B14527750200U1FS0

200 micrometer FlexGuard Fiber with Sheath
OPTICAL INTEGRITY INC
27750200U1FS
Not in Commercial Distribution

  • B14527750200U13FS1 ()
  • B14527750200U1FS0 ()

  • fiber core diameter
  • Outer Diameter: 200 Micrometer


  • General/multiple surgical laser system beam guide, reusable

Flex-G Fiber with Sheath - B145111110

300 micrometer Flex-G Fiber with Sheath
OPTICAL INTEGRITY INC
11111
In Commercial Distribution

  • B145111131 ()
  • B145111110 ()

  • Outer Diameter: 300 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable

Flex-G Fiber with Sheath - B145111070

272 micrometer Flex-G Fiber with Sheath
OPTICAL INTEGRITY INC
11107
In Commercial Distribution

  • B145111091 ()
  • B145111070 ()

  • fiber core diameter
  • Outer Diameter: 272 Micrometer


  • General/multiple surgical laser system beam guide, reusable

Flex-G Fiber with Sheath - B145111030

200 micrometer Flex-G Fiber with Sheath
OPTICAL INTEGRITY INC
11103
In Commercial Distribution

  • B145111051 ()
  • B145111030 ()

  • fiber core diameter
  • Outer Diameter: 200 Micrometer


  • General/multiple surgical laser system beam guide, reusable

Curved Rasp with Elevator - 00887868569920

No Description
Biomet Orthopedics, LLC
903719
In Commercial Distribution

  • 00887868569920 ()
903719

  • Bone file/rasp, manual, reusable

Retinoscopy Rack with Compass - B091151600

No Description
Gulden Ophthalmics Inc.
1
In Commercial Distribution

  • B091151600 ()


  • Trial lens set

Tracheal Stent with Rings - 00815347022420

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-2070-S
In Commercial Distribution

  • 00815347022420 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022413

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-2060-S
In Commercial Distribution

  • 00815347022413 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022406

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1870-S
In Commercial Distribution

  • 00815347022406 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022390

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1850-S
In Commercial Distribution

  • 00815347022390 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022383

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1660-S
In Commercial Distribution

  • 00815347022383 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022376

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1630-S
In Commercial Distribution

  • 00815347022376 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022369

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1490-S
In Commercial Distribution

  • 00815347022369 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022352

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1485-S
In Commercial Distribution

  • 00815347022352 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022345

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1480-S
In Commercial Distribution

  • 00815347022345 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022338

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1475-S
In Commercial Distribution

  • 00815347022338 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022321

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1470-S
In Commercial Distribution

  • 00815347022321 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022314

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1465-S
In Commercial Distribution

  • 00815347022314 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022307

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1460-S
In Commercial Distribution

  • 00815347022307 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022291

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1455-S
In Commercial Distribution

  • 00815347022291 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022284

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1450-S
In Commercial Distribution

  • 00815347022284 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022277

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1445-S
In Commercial Distribution

  • 00815347022277 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022260

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1440-S
In Commercial Distribution

  • 00815347022260 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022253

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1435-S
In Commercial Distribution

  • 00815347022253 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022246

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1430-S
In Commercial Distribution

  • 00815347022246 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Tracheal Stent with Rings - 00815347022239

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
TS-1425-S
In Commercial Distribution

  • 00815347022239 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use
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