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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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Surgical Direct - B382SD5640015B0

Obturator for Use with SD56400-15A
Surgical Direct, Inc.
SD56400-15B
In Commercial Distribution

  • B382SD5640015B0 ()
SD56400-15B

  • Rigid optical cystoscope

Sonoma Orthopedic Products, Inc. - 00816988013174

WRX TRAY WITH INNERMOST TRAY
ARTHREX, INC.
IN0149
Not in Commercial Distribution

  • 00816988013174 ()
IN0149

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867028944

INFLOW CANNULA ADAPTER WITH STOPCOCK
ARTHREX, INC.
AR-3035L
In Commercial Distribution

  • 00888867028944 ()
AR-3035L

  • Rigid optical arthroscope, reusable

Arthrex® - 00888867025981

SMALL HANDLE WITH AO CONNECTION
ARTHREX, INC.
AR-2001AOT
In Commercial Distribution

  • 00888867025981 ()
AR-2001AOT

  • Surgical instrument handle, non-torque-limiting

osseolink Implant - 00816273020740

Surgical Tray with Instrument set
OSSEOLINK USA LLC
STRAY
In Commercial Distribution

  • 00816273020740 ()


  • Dental implant/prosthesis surgical procedure kit

Arthrex® - 00888867021600

DRILL, 2MM WITH DEPTH STOP
ARTHREX, INC.
AR-1822
In Commercial Distribution

  • 00888867021600 ()
AR-1822

  • Fluted surgical drill bit, single-use

Arthrex® - 00888867020962

KINGFISHER 220MM, WITH WISHBONE HANDLE
ARTHREX, INC.
AR-16970W
In Commercial Distribution

  • 00888867020962 ()
AR-16970W

  • Suturing unit, reusable

Arthrex® - 00888867118133

DUALWAVE WITH FOOT PEDAL SET
ARTHREX, INC.
AR-6480-SF
In Commercial Distribution

  • 00888867118133 ()
  • M150AR6480SF0 ()
AR-6480-SF

  • Arthroscopic surgical procedure kit, non-medicated, single-use

Arthrex® - 00888867016286

K-WIRE 1.6 MM WITH BALL
ARTHREX, INC.
AR-14016B
In Commercial Distribution

  • 00888867016286 ()
AR-14016B

  • Orthopaedic intraoperative positioning pin, single-use

Surgical Direct - B382SD7043970

5.5mm Metal Cone with Ties
Surgical Direct, Inc.
SD704397
In Commercial Distribution

  • B382SD7043970 ()
SD704397

  • Laparoscopic access cannula, reusable
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