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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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ZephyrLIFE Home HealthHub Patient Software Application?
ZEPHYR TECHNOLOGY LLC
Software Home
Not in Commercial Distribution

  • 10884521712898 ()
Software Home

  • Electrosurgical return electrode, single-use
hi-PS (Programming Software) Fitting Software, Solo
INTRICON CORPORATION
hi-PS Solo
In Commercial Distribution

  • 00858177007151 ()
23126

  • Hearing aid wireless-fitting computer-aided set
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-04-00-000
In Commercial Distribution

  • 00817100020438 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-03-04-000
In Commercial Distribution

  • 00817100020421 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution

  • 00817100020186 ()


  • Diagnostic x-ray digital imaging system workstation application software
SOFTWARE GE CLIENT SOFTWARE V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123532 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution

  • 04953170360824 ()
N5368940

  • Video capsule endoscopy system application software
Flexible Reamer 6.0, 160mm Cannulated
Trimed, INC.
RMRFLX-6.0/160C
In Commercial Distribution

  • 00842188119477 ()
RMRFLX-6.0/160C

  • Bone-resection orthopaedic reamer, single-use
Interlocking Guide, Drill Sleeve 2.3
Trimed, INC.
SLVGDI-2.3
In Commercial Distribution

  • 00842188119446 ()
SLVGDI-2.3

  • Surgical drill guide, reusable
Hex Driver 3.5, 130mm Cannulated TriLobe
Trimed, INC.
DVHX-3.5/130C TL
In Commercial Distribution

  • 00842188119422 ()
DVHX-3.5/130C TL

  • Surgical screwdriver, reusable
Hex Driver 2.5, 110mm AO Nipple Tip
Trimed, INC.
DVHX-2.5/110N AO
In Commercial Distribution

  • 00842188119385 ()
DVHX-2.5/110N AO

  • Surgical screwdriver, reusable
Radial Shortening Osteotomy Tray
Trimed, INC.
RSO-TRAY
Not in Commercial Distribution

  • 00842188115462 ()
RSO-TRAY

  • Instrument tray, reusable
Radial Osteotomy Saw Guide, 3mm
Trimed, INC.
GSRSO-3
In Commercial Distribution

  • 00842188115455 ()
GSRSO-3

  • Osteotomy guide, reusable
Radial Osteotomy Saw Guide, 2mm
Trimed, INC.
GSRSO-2
In Commercial Distribution

  • 00842188115448 ()
GSRSO-2

  • Osteotomy guide, reusable
Crosslock Guide 2.3
Trimed, INC.
GDXDH-2.3
In Commercial Distribution

  • 00842188115417 ()
GDXDH-2.3

  • Surgical drill guide, reusable
Interlocking Guide, Wire Gauge
Trimed, INC.
SLVWIRE-2.0/125
In Commercial Distribution

  • 00842188115400 ()
SLVWIRE-2.0/125

  • Surgical depth gauge, reusable
Interlocking Guide, Drill Sleeve 2.3, 60mm
Trimed, INC.
SLVGDI-2.3/060
Not in Commercial Distribution

  • 00842188115394 ()
SLVGDI-2.3/060

  • Surgical drill guide, reusable
Impactor, Medial Nail
Trimed, INC.
IMPCT-DHMN
In Commercial Distribution

  • 00842188115387 ()
IMPCT-DHMN

  • Orthopaedic implant impactor, reusable
Interlocking Guide, Medial Nail, Right
Trimed, INC.
GDI-DHMNR
In Commercial Distribution

  • 00842188115370 ()
GDI-DHMNR

  • Surgical drill guide, reusable
Interlocking Guide, Medial Nail, Left
Trimed, INC.
GDI-DHMNL
In Commercial Distribution

  • 00842188115363 ()
GDI-DHMNL

  • Surgical drill guide, reusable
Trajectory Tool
Trimed, INC.
TRJ-DHMN
In Commercial Distribution

  • 00842188115356 ()
TRJ-DHMN

  • Orthopaedic implant aiming/guiding block attachment tool
Flexible Reamer 6.0, 130mm Cannulated
Trimed, INC.
RMRFLX-6.0/130C
In Commercial Distribution

  • 00842188115349 ()
RMRFLX-6.0/130C

  • Bone-resection orthopaedic reamer, single-use
Countersink, Medial Nail Plate
Trimed, INC.
SINKDHF-9.0
In Commercial Distribution

  • 00842188115332 ()
SINKDHF-9.0

  • Surgical countersink, reusable
Ball-tip Guide Wire 1.6, 380mm
Trimed, INC.
BALLWIRE-1.6/380
In Commercial Distribution

  • 00842188115325 ()
BALLWIRE-1.6/380

  • Orthopaedic intraoperative positioning pin, single-use
K-Wire 2.0, 230mm, Double Blunt Tip
Trimed, INC.
WIRE-2.0/230 DB
In Commercial Distribution

  • 00842188115318 ()
WIRE-2.0/230 DB

  • Orthopaedic intraoperative positioning pin, single-use
Hex Driver 2.5, 110mm AO Wide Shaft
Trimed, INC.
DVHX-2.5/110WS AO
In Commercial Distribution

  • 00842188114960 ()
DVHX-2.5/110WS AO

  • Surgical screwdriver, reusable
Hex Driver 2.5, 110mm AO Nipple Tip
Trimed, INC.
DVHX-2.5/060NT AO
Not in Commercial Distribution

  • 00842188114953 ()
DVHX-2.5/060NT AO

  • Surgical screwdriver, reusable
Cluster Plt Screw Drop-in Caddy
Trimed, INC.
AFS-DCADDY
In Commercial Distribution

  • 00842188114885 ()
AFS-DCADDY

  • Instrument tray, reusable
Wolfe Compression Tool
Trimed, INC.
WCC
In Commercial Distribution

  • 00842188113727 ()
WCC

  • Orthopaedic fixation plate tensioner
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