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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The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5071
In Commercial Distribution

  • 04045396006959 ()
5071

  • Hand-held examination/treatment light
The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5070
In Commercial Distribution

  • 04045396006942 ()
5070

  • Hand-held examination/treatment light
I5 Exhaust Condenser (when no vent connection is available)
SKYTRON LLC
I5-CON
In Commercial Distribution

  • 10841736100483 ()
I5-CON

  • Surgical instrument washer/disinfector (chemical/thermal)
Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS02
In Commercial Distribution

  • 08800038405332 ()
  • 18800038405339 ()
  • 28800038405336 ()


  • Non-organic haemostatic agent
Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS01
In Commercial Distribution

  • 08800038405325 ()
  • 18800038405322 ()
  • 28800038405329 ()


  • Non-organic haemostatic agent
Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS03
In Commercial Distribution

  • 18800038405186 ()
  • 08800038405189 ()
  • 28800038405183 ()


  • Non-organic haemostatic agent
NeoSpoon is intended for use as a measuring device.
Neotech Products LLC
1/8 tsp and 1/2 tsp
In Commercial Distribution

  • 00812594012150 ()
  • 10812594012157 ()
N761

  • Medicine spoon, single-use
The deflation needle is used to drain gastric balloons
PRINCE MEDICAL
SN4000718
In Commercial Distribution

  • 03665039001663 ()
SN4000718

  • Gastrointestinal needle catheter
Giotto Image is a conventional film-screen x-ray mammographic device.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
GIOTTO IMAGE SRA
In Commercial Distribution

  • 18033837190117 ()
  • 08033837190110 ()

  • Height: 2240 Millimeter
  • Depth: 1140 Millimeter
  • Width: 1150 Millimeter
6702

  • Stationary mammographic x-ray system, digital
Giotto Image is a conventional film-screen x-ray mammographic device.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
GIOTTO IMAGE M
In Commercial Distribution

  • 08033837190103 ()
  • 18033837190100 ()

  • Height: 2240 Millimeter
  • Depth: 1140 Millimeter
  • Width: 1150 Millimeter
6501

  • Stationary mammographic x-ray system, digital
FMH-139 is a One Step HCG Urine Pregnancy Test
Sevenground Trading B.V.
FMH-139-3
In Commercial Distribution

  • 08719699633254 ()
  • 08719699633643 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
FMH-139 is a One Step HCG Urine Pregnancy Test
Sevenground Trading B.V.
FMH-139-5
In Commercial Distribution

  • 08719699633230 ()
  • 08719699633636 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
K-NS-356-60 is a better breath Stop Snoring Nasal Strips
Sevenground Trading B.V.
K-NS-356-60
In Commercial Distribution

  • 08719699632714 ()
  • 08719699633629 ()


  • Nasal breathing aid, external
K-NS-356 is a better breath Stop Snoring Nasal Strips
Sevenground Trading B.V.
K-NS-356-30
In Commercial Distribution

  • 08719699632448 ()
  • 08719699633612 ()


  • Nasal breathing aid, external
FMH-139 is a One Step HCG Urine Pregnancy Test
Sevenground Trading B.V.
FMH-139-5
In Commercial Distribution

  • 08719699636408 ()
  • 08719699630901 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
MULTI HOLE SUCTION TUBE 23CM CAP IS FIXATED / NON-REMOVABLE
SURGIX MEDICAL LLC
G2G35878
In Commercial Distribution

  • 00840343715342 ()

  • Length: 24.75 Centimeter
  • working length 10.5 cm
G2G35878

  • Suction system catheter, general-purpose
Quick Tip Wrench is not considered a medical device.
AMERICAN EAGLE INSTRUMENTS, INC.
AEQTW
Not in Commercial Distribution

  • 00841013109980 ()


  • Manual non-rotary dental instrument handle
PRO CON PL TIB IS TR RT S1 30
Smith & Nephew, Inc.
71518118
In Commercial Distribution

  • 03596010225993 ()
71518118

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 18
Smith & Nephew, Inc.
71518115
In Commercial Distribution

  • 03596010225962 ()
71518115

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 14
Smith & Nephew, Inc.
71518113
In Commercial Distribution

  • 03596010225948 ()
71518113

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 20
Smith & Nephew, Inc.
71518116
In Commercial Distribution

  • 03596010225979 ()
71518116

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 16
Smith & Nephew, Inc.
71518114
In Commercial Distribution

  • 03596010225955 ()
71518114

  • Knee tibia prosthesis trial, reusable
TOURNIK-IT is a hemostasis system used to control bleeding
FLAMOR SRL
TK-00
In Commercial Distribution

  • 08057592700025 ()


  • Venous tourniquet, reusable
The Glenoid Drill Shaft is used to create holes.
Ascension Orthopedics, Inc.
DRS-0926-001
In Commercial Distribution

  • M269DRS09260011 ()
  • 10381780258308 ()


  • Surgical drill guide, reusable
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
In Commercial Distribution

  • 07630039101404 ()
19880.0005

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
In Commercial Distribution

  • 07630039101398 ()
21362.0102

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
  • Dermatological extracorporeal shock wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
Not in Commercial Distribution

  • 07630039101336 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
Not in Commercial Distribution

  • 07630039101329 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
Intelect F-SW USA
In Commercial Distribution

  • 07630039101312 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443S
In Commercial Distribution

  • M269SHP443S1 ()
  • 10381780237181 ()

  • Size Small; .405 in dia
SHP-443-S

  • Bone cutter
The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443M
In Commercial Distribution

  • M269SHP443M1 ()
  • 10381780237174 ()

  • Size Medium; .458 in dia
SHP-443-M

  • Bone cutter
The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443L
In Commercial Distribution

  • M269SHP443L1 ()
  • 10381780237167 ()

  • Size Large; .520 in dia
SHP-443-L

  • Bone cutter
In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
72-00204-0
In Commercial Distribution

  • 00817183020592 ()
7209944

  • Insufflation gas conditioning system control unit
In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
6-810-00
In Commercial Distribution

  • 00817183020240 ()


  • Insufflation gas conditioning system control unit
In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
6-820-00
In Commercial Distribution

  • 00817183020233 ()


  • Insufflation gas conditioning system control unit
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T3 4°
In Commercial Distribution

  • 07640167930319 ()
GL303000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T2 4°
In Commercial Distribution

  • 07640167930302 ()
GL203000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T2 4°
In Commercial Distribution

  • 07640167930272 ()
GT202000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 Deg
In Commercial Distribution

  • 07640167930067 ()
48291437S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930050 ()
48291432S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 Deg
In Commercial Distribution

  • 07640167930043 ()
48291427S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930036 ()
48291422S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 Deg
In Commercial Distribution

  • 07640167930029 ()
48291485S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930012 ()
48291482S

  • Vertebral body prosthesis
MAGSCREEN Serenity is the remote display for MAGLIFE Serenity
SCHILLER MEDICAL
MAGSCREEN Serenity
In Commercial Distribution

  • 07613365900019 ()
1-096-9900

  • General-purpose multi-parameter bedside monitor
The PowerCube Diffusion+ is equipped with the MultiX Trolley.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501254 ()


  • Pulmonary function analysis system, adult
The PowerCube Diffusion+ is equipped with the MultiX Trolley.
Ganshorn Medizin Electronic GmbH
A
Not in Commercial Distribution

  • 07613365500301 ()


  • Pulmonary function analysis system, adult
Patient-Use Tubing, Do not use if package is damaged
STRYKER CORPORATION
0450000125
In Commercial Distribution

  • 37613327261036 ()
  • 07613327261035 ()
0450-000-125

  • Surgical irrigation/aspiration tubing set
The clamp holder is used to grip the implant.
NEWDEAL
239500ND
Not in Commercial Distribution

  • M248239500ND1 ()
  • 10381780051923 ()


  • Surgical implant handling forceps
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1056
In Commercial Distribution

  • E22110561 ()
1056

  • Dental composite resin
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