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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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Exact Medical Manufacturing, Inc. - 00850015378119

XXL Fabric Reinforced Surgical Gowns
EXACT MEDICAL MANUFACTURING, INC.
E105270
Not in Commercial Distribution

  • 00850015378126 ()
  • 00850015378119 ()
E105270

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00850015378096

XL Fabric Reinforced Surgical Gown
EXACT MEDICAL MANUFACTURING, INC.
E105260
Not in Commercial Distribution

  • 00850015378102 ()
  • 00850015378096 ()
E105260

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00850015378072

Large Fabric Reinforced Surgical Gown
EXACT MEDICAL MANUFACTURING, INC.
E105250
Not in Commercial Distribution

  • 00850015378089 ()
  • 00850015378072 ()
E105250

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00850015378058

XXL AAMI 3 Non-Reinforced Surgical Gowns
EXACT MEDICAL MANUFACTURING, INC.
E105170
Not in Commercial Distribution

  • 00850015378065 ()
  • 00850015378058 ()
E105170

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00850015378034

XL AAMI 3 Non-Reinforced Surgical Gown
EXACT MEDICAL MANUFACTURING, INC.
E105160
Not in Commercial Distribution

  • 00850015378041 ()
  • 00850015378034 ()
E105160

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00850015378010

Large AAMI 3 Non-Reinforced Surgical Gown
EXACT MEDICAL MANUFACTURING, INC.
E105150
Not in Commercial Distribution

  • 00850015378027 ()
  • 00850015378010 ()
E105150

  • Surgical gown, single-use

RIGICON SURGICAL RETRACTOR - 00850015358746

Rigicon® Surgical Retractor
Rigicon, Inc.
RSRK-1000
In Commercial Distribution

  • 00850015358746 ()
RSRK-1000

  • Surgical retraction system, single-use

Rigicon HL Dilator 10 – 12 mm - 00850015358449

Rigicon HL Dilator 10 – 12 mm Disposable
Rigicon, Inc.
RSUD-1012
In Commercial Distribution

  • 00850015358449 ()
RSUD-1012

  • Penile prosthesis implantation instrument

Rigicon HL Dilator 15 – 16 mm - 00850015358432

Rigicon HL Dilator 15 – 16 mm Disposable
Rigicon, Inc.
RSUD-1516
In Commercial Distribution

  • 00850015358432 ()
RSUD-1516

  • Penile prosthesis implantation instrument

Rigicon HL Dilator 13 – 14 mm - 00850015358425

Rigicon HL Dilator 13 – 14 mm
Rigicon, Inc.
RSUD-1314
In Commercial Distribution

  • 00850015358425 ()
RSUD-1314

  • Penile prosthesis implantation instrument

Rigicon HL Dilator 11 – 12 mm - 00850015358418

Rigicon HL Dilator 11 – 12 mm Disposable
Rigicon, Inc.
RSUD-1112
In Commercial Distribution

  • 00850015358418 ()
RSUD-1112

  • Penile prosthesis implantation instrument

Rigicon HL Dilator 09 – 10 mm - 00850015358401

Rigicon HL Dilator 09 – 10 mm Disposable
Rigicon, Inc.
RSUD-0910
In Commercial Distribution

  • 00850015358401 ()
RSUD-0910

  • Penile prosthesis implantation instrument

Rigicon Furlow Insertion Tool - 00850015358395

SINGLE USE DISPOSABLE FURLOW INSERTION TOOL
Rigicon, Inc.
RSUF-1000
In Commercial Distribution

  • 00850015358395 ()
RSUF-1000

  • Penile prosthesis implantation instrument

Rigicon Stainless Steel Dilator 10-12 mm - 00850015358326

Rigicon Stainless Steel Dilator 10-12 mm
Rigicon, Inc.
RSSD-1012
In Commercial Distribution

  • 00850015358326 ()
RSSD-1012

  • Corpus cavernosum dilator, reusable

Rigicon Stainless Steel Dilator 13-14 mm - 00850015358319

Rigicon Stainless Steel Dilator 13-14 mm
Rigicon, Inc.
RSSD-1314
In Commercial Distribution

  • 00850015358319 ()
RSSD-1314

  • Corpus cavernosum dilator, reusable

Rigicon Stainless Steel Dilator 11-12 mm - 00850015358302

Rigicon Stainless Steel Dilator 11-12 mm
Rigicon, Inc.
RSSD-1112
In Commercial Distribution

  • 00850015358302 ()
RSSD-1112

  • Corpus cavernosum dilator, reusable

Rigicon Stainless Steel Dilator 09-10 mm - 00850015358296

Rigicon Stainless Steel Dilator 09-10 mm
Rigicon, Inc.
RSSD-0910
In Commercial Distribution

  • 00850015358296 ()
RSSD-0910

  • Corpus cavernosum dilator, reusable

Rigicon Stainless Steel Furlow Insertion Tool - 00850015358289

Rigicon Stainless Steel Furlow Insertion Tool
Rigicon, Inc.
RSSF-1000
In Commercial Distribution

  • 00850015358289 ()
RSSF-1000

  • Gastro-urological director

6070A - 00850015328060

No Description
ARC MEDICAL INC.
6070A
In Commercial Distribution

  • 50850015328065 ()
  • 00850015328060 ()
  • 40850015328068 ()
  • 30850015328061 ()
  • 20850015328064 ()
  • 10850015328067 ()


  • Heat/moisture exchanger/microbial medical gas filter

6060A - 00850015328053

No Description
ARC MEDICAL INC.
6060A
In Commercial Distribution

  • 40850015328051 ()
  • 00850015328053 ()
  • 30850015328054 ()
  • 20850015328057 ()
  • 10850015328050 ()


  • Heat/moisture exchanger/microbial medical gas filter

6000A - 00850015328046

No Description
ARC MEDICAL INC.
6000A
In Commercial Distribution

  • 40850015328044 ()
  • 00850015328046 ()
  • 30850015328047 ()
  • 20850015328040 ()
  • 10850015328043 ()


  • Heat/moisture exchanger/microbial medical gas filter

7056A - 00850015328039

No Description
ARC MEDICAL INC.
7056A
In Commercial Distribution

  • 40850015328037 ()
  • 00850015328039 ()
  • 30850015328030 ()
  • 20850015328033 ()
  • 10850015328036 ()
  • 50850015328034 ()


  • Heat/moisture exchanger/microbial medical gas filter

6130A - 00850015328022

No Description
ARC MEDICAL INC.
6130A
In Commercial Distribution

  • 50850015328027 ()
  • 00850015328022 ()
  • 40850015328020 ()
  • 30850015328023 ()
  • 20850015328026 ()
  • 10850015328029 ()


  • Heat/moisture exchanger/microbial medical gas filter

6126A - 00850015328015

No Description
ARC MEDICAL INC.
6126A
In Commercial Distribution

  • 40850015328013 ()
  • 00850015328015 ()
  • 30850015328016 ()
  • 20850015328019 ()
  • 10850015328012 ()
  • 50850015328010 ()


  • Heat/moisture exchanger/microbial medical gas filter

6120A - 00850015328008

No Description
ARC MEDICAL INC.
6120A
In Commercial Distribution

  • 20850015328002 ()
  • 00850015328008 ()
  • 10850015328005 ()


  • Heat/moisture exchanger/microbial medical gas filter

Sleep Profiler PSG2 - 00850015266997

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(SWISS)
In Commercial Distribution

  • 00850015266997 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266980

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(GER)
In Commercial Distribution

  • 00850015266980 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00850015266973

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(SWISS)
In Commercial Distribution

  • 00850015266973 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler - 00850015266966

Sleep Profiler LE Device Kit Swiss
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(SWISS)
In Commercial Distribution

  • 00850015266966 ()


  • Electroencephalograph

Sleep Profiler - 00850015266959

Sleep Profiler LE Device Kit French
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(FRE)
In Commercial Distribution

  • 00850015266959 ()


  • Electroencephalograph
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