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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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It is a part intended to obtain the exact implant position information to transfer it to the correct position of a 3D model.
Shining 3D Tech Co., Ltd.
HACS-A20-3
In Commercial Distribution

  • 06970163081977 ()


  • Dental implant abutment analog, laboratory
It is a part intended to obtain the exact implant position information to transfer it to the correct position of a 3D model.
Shining 3D Tech Co., Ltd.
HACS-A20-2
In Commercial Distribution

  • 06970163081960 ()


  • Dental implant abutment analog, laboratory
It is a part intended to obtain the exact implant position information to transfer it to the correct position of a 3D model.
Shining 3D Tech Co., Ltd.
HACS-A20-1
In Commercial Distribution

  • 06970163081946 ()


  • Dental implant abutment analog, laboratory
It is a part intended to obtain the exact implant position information to transfer it to the correct position of a 3D model.
Shining 3D Tech Co., Ltd.
HACS-A15-3
In Commercial Distribution

  • 06970163081939 ()


  • Dental implant abutment analog, laboratory
It is a part intended to obtain the exact implant position information to transfer it to the correct position of a 3D model.
Shining 3D Tech Co., Ltd.
HACS-A15-2
In Commercial Distribution

  • 06970163081922 ()


  • Dental implant abutment analog, laboratory
It is a part intended to obtain the exact implant position information to transfer it to the correct position of a 3D model.
Shining 3D Tech Co., Ltd.
HACS-A15-1
In Commercial Distribution

  • 06970163081908 ()


  • Dental implant abutment analog, laboratory
Reagent associated to all API references except API LISTERIA (10 300) 1 API ZYM (25 200) to close the cupule to the atmosphere
BIOMERIEUX SA
70100
In Commercial Distribution

  • 03573026099442 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
The Lance Pilot Drill is used to penetrate the cortical bone in order to mark the site and to guide the subsequent drills.
STERNGOLD DENTAL LLC
903014
In Commercial Distribution

  • 00841549110092 ()


  • Fixture/appliance dental drill bit, reusable
Used to remove dental calculus. Also, it is used to remove foreign substances in the middle to apical area of the root canal.
BioMTA
BUST-03
In Commercial Distribution

  • 08800027200108 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
The GATOR is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.
Vascular Solutions, Inc.
8280
Not in Commercial Distribution

  • M20682800 ()
  • M20682801 ()


  • In-line backflow valve, single-use
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6120
In Commercial Distribution

  • M84961200 ()
6120

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6118
In Commercial Distribution

  • M84961180 ()
6118

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6117
In Commercial Distribution

  • M84961170 ()
6117

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6115
In Commercial Distribution

  • M84961150 ()
6115

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6113
In Commercial Distribution

  • M84961130 ()
6113

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6112
In Commercial Distribution

  • M84961120 ()
6112

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6111
In Commercial Distribution

  • M84961110 ()
6111

  • Polymeric biliary stent, non-bioabsorbable
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer designed as a continuous tube with retention flanges. Single use device.
HOBBS MEDICAL, INC.
6110
In Commercial Distribution

  • M84961100 ()
6110

  • Polymeric biliary stent, non-bioabsorbable
The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field.
ENDOAID LTD
E103
In Commercial Distribution

  • 07290016767032 ()
  • 17290016767039 ()
  • 27290016767036 ()

  • Height: 24 Millimeter
  • Ø50nn


  • Colonoscope distal anchoring cuff
The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field.
ENDOAID LTD
E102
In Commercial Distribution

  • 07290016767025 ()
  • 17290016767022 ()
  • 27290016767029 ()

  • Height: 24 Millimeter
  • Ø50mm


  • Colonoscope distal anchoring cuff
IOS based APP used to control Evok Ri RIC device (On-the-Ear OTE). Wirelessly control memory/situational environments, control bass & treble using equalizers. Turn on/off functions.
Persona Medical
Persona Ri APP
In Commercial Distribution

  • 00851362008605 ()


  • Air-conduction hearing aid, behind-the-ear
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software
Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5504-06-300
In Commercial Distribution

  • 00817491024275 ()
FG-5504-06-300

  • Implantable glucose monitoring system
Bullfrog HVE to Saliva Ejector Tubing Adapter
HAGER WORLDWIDE, INC.
B11127
In Commercial Distribution

  • D248B111270 ()


  • Dental suction system
Bullfrog Saliva Ejector to HVE Tubing Adapter
HAGER WORLDWIDE, INC.
B11128
In Commercial Distribution

  • D248B111280 ()


  • Dental suction system
No Description
FLEXICARE MEDICAL LIMITED
010-741U
In Commercial Distribution

  • 05055788761945 ()


  • Hydrophobic Luer filter
No Description
MASIMO CORPORATION
3983
In Commercial Distribution

  • 00843997009676 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
2654
In Commercial Distribution

  • 00843997003933 ()


  • Electrical-only medical device connection cable, reusable
MasimoSET LNC-MAC-GE LNCS®to GE Adapter Cable
MASIMO CORPORATION
2264
In Commercial Distribution

  • 00843997000796 ()
2264

  • Electrical-only medical device connection cable, reusable
MasimoSET LNC-MAC-SL LNCS to Spacelabs Adapter Cable
MASIMO CORPORATION
2266
In Commercial Distribution

  • 00843997000789 ()
2266

  • Electrical-only medical device connection cable, reusable
MasimoSET LNC-10-GE LNCS to GE Patient Cable
MASIMO CORPORATION
2016
In Commercial Distribution

  • 00843997000550 ()
2016

  • Electrical-only medical device connection cable, reusable
MasimoSET LNCS® to PC Adapter Cable
MASIMO CORPORATION
1816
In Commercial Distribution

  • 00843997000536 ()
1816

  • Electrical-only medical device connection cable, reusable
Leica Biosystems CytoVision GSL10 to GSL120 Stacker Upgrade
Leica Biosystems Richmond, Inc.
23GSL010UPG120
Not in Commercial Distribution

  • 00849832004448 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Update to CytoVision current version
Leica Biosystems Richmond, Inc.
23SWR000CVX999
Not in Commercial Distribution

  • 00849832004295 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Final Bacteria Filter - 1/4in to 1/2in
SUNSET HEALTHCARE SOLUTIONS, INC.
BF1412-1
In Commercial Distribution

  • 00848530010720 ()
BF1412-1

  • Anaesthesia conduction filter
Final Bacteria Filter - 3/8in to 1/2in
SUNSET HEALTHCARE SOLUTIONS, INC.
BF3812-1
In Commercial Distribution

  • 00848530010713 ()
BF3812-1

  • Anaesthesia conduction filter
Final Bacteria Filters — 3/8in to 1/2in
SUNSET HEALTHCARE SOLUTIONS, INC.
BF3812
In Commercial Distribution

  • 00848530010553 ()
  • 10848530010550 ()
BF3812

  • Anaesthesia conduction filter
Final Bacteria Filter - 1/4in to 3/8in
SUNSET HEALTHCARE SOLUTIONS, INC.
BF1438-1
In Commercial Distribution

  • 00848530010416 ()
BF1438-1

  • Anaesthesia conduction filter
Final Bacteria Filters - 1/4in to 3/8in
SUNSET HEALTHCARE SOLUTIONS, INC.
BF1438
In Commercial Distribution

  • 00848530010409 ()
  • 10848530010406 ()
BF1438

  • Anaesthesia conduction filter
Final Bacteria Filters — 1/4in to 1/2in
SUNSET HEALTHCARE SOLUTIONS, INC.
BF1412
In Commercial Distribution

  • 00848530010386 ()
  • 10848530010383 ()
BF1412

  • Anaesthesia conduction filter
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