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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Union Broach® Reamers #8 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12061
Not in Commercial Distribution

  • H834012120611 ()
  • 10381780481713 ()
  • 00381780481716 ()
012-12061

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #80 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12016
Not in Commercial Distribution

  • H834012120161 ()
  • 10381780481706 ()
  • 00381780481709 ()
012-12016

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #70 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12015
Not in Commercial Distribution

  • H834012120151 ()
  • 10381780481690 ()
  • 00381780481693 ()
012-12015

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #60 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12014
Not in Commercial Distribution

  • H834012120141 ()
  • 10381780481683 ()
  • 00381780481686 ()
012-12014

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #55 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12013
Not in Commercial Distribution

  • H834012120131 ()
  • 10381780481676 ()
  • 00381780481679 ()
012-12013

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #50 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12012
Not in Commercial Distribution

  • H834012120121 ()
  • 10381780481669 ()
  • 00381780481662 ()
012-12012

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #45 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12011
Not in Commercial Distribution

  • H834012120111 ()
  • 10381780481652 ()
  • 00381780481655 ()
012-12011

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #40 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12009
Not in Commercial Distribution

  • H834012120091 ()
  • 10381780481645 ()
  • 00381780481648 ()
012-12009

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12008
Not in Commercial Distribution

  • H834012120081 ()
  • 10381780481638 ()
  • 00381780481631 ()
012-12008

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #30 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12007
Not in Commercial Distribution

  • H834012120071 ()
  • 10381780481621 ()
  • 00381780481624 ()
012-12007

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #25 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12006
Not in Commercial Distribution

  • H834012120061 ()
  • 10381780481614 ()
  • 00381780481617 ()
012-12006

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #20 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12005
Not in Commercial Distribution

  • H834012120051 ()
  • 10381780481607 ()
  • 00381780481600 ()
012-12005

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #15 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12004
Not in Commercial Distribution

  • H834012120041 ()
  • 10381780481591 ()
  • 00381780481594 ()
012-12004

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #10 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12003
Not in Commercial Distribution

  • H834012120031 ()
  • 10381780481584 ()
  • 00381780481587 ()
012-12003

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #8 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12002
Not in Commercial Distribution

  • H834012120021 ()
  • 10381780481577 ()
  • 00381780481570 ()
012-12002

  • Manual endodontic file/rasp, single-use
Symmetry® Dilator, Bakes Common Duct, 13.0 mm Tip Width, 11 3/4 in
SYMMETRY SURGICAL INC.
51-0613
In Commercial Distribution

  • 00887482075210 ()

  • Length: 11.75 Inch
  • Width: 13 Millimeter
51-0613

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 11 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0511
In Commercial Distribution

  • 00887482075173 ()

  • Length: 8.5 Inch
  • Width: 11 Millimeter
51-0511

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 10 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0510
In Commercial Distribution

  • 00887482075166 ()

  • Length: 8.5 Inch
  • Width: 10 Millimeter
51-0510

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 9 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0509
In Commercial Distribution

  • 00887482075159 ()

  • Length: 8.5 Inch
  • Width: 9 Millimeter
51-0509

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 7 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0507
In Commercial Distribution

  • 00887482075135 ()

  • Length: 8.5 Inch
  • Width: 7 Millimeter
51-0507

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 6 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0506
In Commercial Distribution

  • 00887482075128 ()

  • Length: 8.5 Inch
  • Width: 6 Millimeter
51-0506

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 5 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0505
In Commercial Distribution

  • 00887482075111 ()

  • Length: 8.5 Inch
  • Width: 5 Millimeter
51-0505

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 4 mm Tip Width, 8 1/2 in
SYMMETRY SURGICAL INC.
51-0504
In Commercial Distribution

  • 00887482075104 ()

  • Length: 8.5 Inch
  • Width: 4 Millimeter
51-0504

  • Common bile duct dilator
OTS - Joint Safety Institute Field Kit
Certified Safety Manufacturing, Inc.
K616-077
In Commercial Distribution

  • 00766588160771 ()
K616-077

  • Eye pad
  • First aid kit, medicated
  • Adhesive bandage
  • Non-woven gauze roll/sheet
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Non-rebreathing valve, single-use
  • Cardiopulmonary resuscitation mask, single-use
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-woven gauze pad
  • Endothermic cold therapy pack
ZLB - Joint Safety Institute Small Cut
Certified Safety Manufacturing, Inc.
K616-075
In Commercial Distribution

  • 00766588160757 ()
K616-075

  • First aid kit, medicated
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM43
In Commercial Distribution

  • 50197106370672 ()
  • 10197106370674 ()
SCV31HVM43

  • Cardiothoracic surgical procedure kit, medicated, single-use
ZLB - Joint Safety Institute Large Wound
Certified Safety Manufacturing, Inc.
K616-076
In Commercial Distribution

  • 00766588160764 ()
K616-076

  • First aid kit, medicated
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJB8
In Commercial Distribution

  • 50197106368167 ()
  • 10197106368169 ()
SOP13BUJB8

  • Orthopaedic surgical procedure kit, non-medicated, single-use
HEART VALVE INSTITUTE BASIN PK
Cardinal Health 200, LLC
SBA31BXMY5
In Commercial Distribution

  • 50197106366873 ()
  • 10197106366875 ()
SBA31BXMY5

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWBB
In Commercial Distribution

  • 50195594788016 ()
  • 10195594788018 ()
SOPMIBPWBB

  • General surgical procedure kit, medicated
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWB2
In Commercial Distribution

  • 50195594785275 ()
  • 10195594785277 ()
SOPMIBPWB2

  • General surgical procedure kit, medicated
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM33
In Commercial Distribution

  • 50195594764539 ()
  • 10195594764531 ()
SCV31HVM33

  • Cardiothoracic surgical procedure kit, medicated, single-use
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWB1
In Commercial Distribution

  • 50195594763655 ()
  • 10195594763657 ()
SOPMIBPWB1

  • General surgical procedure kit, medicated
Caresono HD2 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes.
Caresono Technology Co.,Ltd.
HD2
In Commercial Distribution

  • 16971003430037 ()


  • Bladder volume ultrasound imaging system
Caresono HD3 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes.
Caresono Technology Co.,Ltd.
HD3
In Commercial Distribution

  • 16971003430020 ()


  • Bladder volume ultrasound imaging system
Caresono HD5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes.
Caresono Technology Co.,Ltd.
HD5
In Commercial Distribution

  • 16971003430013 ()


  • Bladder volume ultrasound imaging system
Symmetry® Dilator, Ruedemann Lacrimal, Short
SYMMETRY SURGICAL INC.
60-1996
In Commercial Distribution

  • 00887482111468 ()
60-1996

  • Common bile duct dilator
Symmetry® Dilator, Wilder, Medium, 4 in
SYMMETRY SURGICAL INC.
60-1994
In Commercial Distribution

  • 00887482111444 ()

  • Length: 4 Inch
60-1994

  • Common bile duct dilator
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWB5
In Commercial Distribution

  • 50197106185726 ()
  • 10197106185728 ()
SOPMIBPWB5

  • General surgical procedure kit, medicated
Symmetry® Dilator, Wilder, Long, 4 in
SYMMETRY SURGICAL INC.
60-1995
In Commercial Distribution

  • 00887482111451 ()

  • Length: 4 Inch
60-1995

  • Common bile duct dilator
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