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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No Description
BIOTECHNOLOGY INSTITUTE SL
DC24
In Commercial Distribution

  • 08435389801795 ()


  • Surgical screwdriver, reusable
Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
REDAX SPA
10526
In Commercial Distribution

  • 18034139296606 ()
  • 08034139296609 ()
10526

  • Closed-wound drain connector
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21824
In Commercial Distribution

  • 18034139293780 ()
  • 08034139293783 ()
21824

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20824
In Commercial Distribution

  • 18034139292844 ()
  • 08034139292847 ()
20824

  • Pleural catheter
Ocean Ergo XL Dir. Lock
INVACARE CORPORATION
1603080
In Commercial Distribution

  • 04028698132564 ()

  • 1
1603080, 1603157

  • Shower seat, non-powered
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1650-A
In Commercial Distribution

  • 04050674077675 ()
1650-A

  • Microhaematocrit centrifuge IVD
No Description
RPI
LSU002
In Commercial Distribution

  • 00841034114703 ()
LSU002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSR002
In Commercial Distribution

  • 00841034114666 ()
LSR002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSN002
In Commercial Distribution

  • 00841034114628 ()
LSN002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSG002
In Commercial Distribution

  • 00841034114581 ()
LSG002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSE002
In Commercial Distribution

  • 00841034114567 ()
LSE002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSB002
In Commercial Distribution

  • 00841034114529 ()
LSB002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPW002
In Commercial Distribution

  • 00841034114482 ()
LPW002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPU002
In Commercial Distribution

  • 00841034114468 ()
LPU002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPR002
In Commercial Distribution

  • 00841034114420 ()
LPR002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPB002
In Commercial Distribution

  • 00841034114284 ()
LPB002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSW002
In Commercial Distribution

  • 00841034114727 ()
LSW002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPN002
In Commercial Distribution

  • 00841034114383 ()
LPN002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPG002
In Commercial Distribution

  • 00841034114345 ()
LPG002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPE002
In Commercial Distribution

  • 00841034114321 ()
LPE002

  • Electrocardiographic lead set, reusable
No Description
Eckert & Ziegler BEBIG GmbH
LAH02-24#03
Not in Commercial Distribution

  • 04049223106621 ()
LAH02-24

  • General-purpose brachytherapy system applicator, remote-afterloading
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1650
In Commercial Distribution

  • 04050674030441 ()
1650

  • Microhaematocrit centrifuge IVD
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1023
In Commercial Distribution

  • 04050674030427 ()
1023

  • Microhaematocrit centrifuge IVD
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363246
In Commercial Distribution

  • 09421028118460 ()
287363246

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363244
In Commercial Distribution

  • 09421028118446 ()
287363244

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET20224T
In Commercial Distribution

  • 09421028118385 ()
LET20224T

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET30324T
In Commercial Distribution

  • 09421028118361 ()
LET30324T

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered
This is a medical device.
KaVo Dental GmbH
0.571.5621
In Commercial Distribution

  • EKAV057156210 ()
rootplaner Tip No 24

  • Ultrasonic dental scaling/debridement system
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5844-17
In Commercial Distribution

  • 00842430104374 ()
  • 00842430111860 ()
5844-17

  • Medical equipment/instrument drape, single-use
No Description
Axiodent Inc.
28019
In Commercial Distribution

  • D161280190 ()


  • Denture trial fabrication wax
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69453
In Commercial Distribution

  • 00842430100673 ()
69453

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69452
In Commercial Distribution

  • 00842430100666 ()
69452

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69444
In Commercial Distribution

  • 00842430100659 ()
69444

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69442
In Commercial Distribution

  • 00842430100604 ()
69442

  • Operating table mattress, basic
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301124-000
In Commercial Distribution

  • B0663011240000 ()
  • B0663011240006 ()
301124-000

  • Cardiopulmonary bypass system priming set
PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF
Origio A/S
ART-2024
In Commercial Distribution

  • 60888937818583 ()


  • IVF medium kit
No Description
ACCUTRON, INC.
26433-FRU
In Commercial Distribution

  • 00813830026177 ()
26433-FRU

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
25096-FRU
In Commercial Distribution

  • 00813830026153 ()
25096-FRU

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
33017-9
In Commercial Distribution

  • 00813830025866 ()
33017-9

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-17
In Commercial Distribution

  • 00813830025859 ()
33017-17

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-12
In Commercial Distribution

  • 00813830025842 ()
33017-12

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-11
In Commercial Distribution

  • 00813830025835 ()
33017-11

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-10
In Commercial Distribution

  • 00813830025828 ()
33017-10

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-1
In Commercial Distribution

  • 00813830025811 ()
33017-1

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-9
In Commercial Distribution

  • 00813830025804 ()
33016-9

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-16
In Commercial Distribution

  • 00813830025774 ()
33016-16

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-15
In Commercial Distribution

  • 00813830025767 ()
33016-15

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-14
In Commercial Distribution

  • 00813830025750 ()
33016-14

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-12
In Commercial Distribution

  • 00813830025736 ()
33016-12

  • Anaesthesia face mask, single-use
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