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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QINFLOW WARRIOR HYBRID INTRO SET - The QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body. The kit contains 1 battery and AC Power supply module. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 17290016740049 ()


  • Conduction blood/fluid warmer
Fluido® Compact Control Module
The Surgical Company International B.V.
Control Module
In Commercial Distribution

  • 18719867002421 ()
650100-US

  • Conduction blood/fluid warmer
Fluido® Compact Warming Module
The Surgical Company International B.V.
Warming Module
In Commercial Distribution

  • 18719867001561 ()
650200

  • Conduction blood/fluid warmer
QinFlow Warrior Lite Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a LED panel display for user notifications.
QUALITY IN FLOW LTD
QIF-03
In Commercial Distribution

  • 07290016740103 ()
QIF03-BUA1000

  • Conduction blood/fluid warmer
QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body. The kit contains 2 batteries. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
QIF-01-12
In Commercial Distribution

  • 07290016740097 ()
Q1220S1000U

  • Conduction blood/fluid warmer
QinFlow Warrior Extreme Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.
QUALITY IN FLOW LTD
QIF-01-12
In Commercial Distribution

  • 07290016740073 ()
QPORT1100U12

  • Conduction blood/fluid warmer
QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 07290016740011 ()
QPORT1100U

  • Conduction blood/fluid warmer
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief.
INDACO SRL
35 LE
In Commercial Distribution

  • 05391512286651 ()
  • 05391512281359 ()
35

  • Wrist/hand/metacarpophalangeal joint extension orthosis
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief.
INDACO SRL
35 LR
In Commercial Distribution

  • 05391512286644 ()
  • 05391512281342 ()
35

  • Wrist/hand/metacarpophalangeal joint extension orthosis
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief.
INDACO SRL
35 LS
In Commercial Distribution

  • 05391512286637 ()
  • 05391512281335 ()
35

  • Wrist/hand/metacarpophalangeal joint extension orthosis
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief.
INDACO SRL
35 RE
In Commercial Distribution

  • 05391512286620 ()
  • 05391512281328 ()
35

  • Wrist/hand/metacarpophalangeal joint extension orthosis
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief.
INDACO SRL
35 RR
In Commercial Distribution

  • 05391512286613 ()
  • 05391512281311 ()
35

  • Wrist/hand/metacarpophalangeal joint extension orthosis
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief.
INDACO SRL
35 RS
In Commercial Distribution

  • 05391512286606 ()
  • 05391512281304 ()
35

  • Wrist/hand/metacarpophalangeal joint extension orthosis
Tinted Opaque Powder
JBC and Company
35
In Commercial Distribution

  • D85135 ()
35

  • Dental appliance fabrication material, resin
No Description
MANI, INC.
35
In Commercial Distribution

  • 04546951500283 ()
  • 14546951500280 ()
35

  • Nylon suture, non-bioabsorbable, monofilament
Cutaneous Electrode Garment
AXIOBIONICS
0
In Commercial Distribution

  • B3673500 ()
35

  • Transcutaneous electrical stimulation electrode, single-use
3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Left Cuspids, Size 35, 35
3M COMPANY
35
In Commercial Distribution

  • 50605861025138 ()
  • 30605861025134 ()
  • 00605861022217 ()
35

  • Preformed dental crown, temporary
Stoggles round blush standard (with blue blocking + anti-fog)
Stoggles Inc.
35
In Commercial Distribution

  • 00850023503381 ()


  • Spectacle frame
Fecal Immunochemical Test to screen for Colorectal Cancer.
Home Access Health Corporation
35
In Commercial Distribution

  • M769FITCHEK351 ()


  • Faecal specimen collection kit IVD, home-use
No Description
Merete GmbH
35
In Commercial Distribution

  • 04048266167507 ()
FH03035

  • Orthopaedic fixation plate, non-bioabsorbable
SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
FUJI SYSTEMS CORPORATION
#35
In Commercial Distribution

  • 04544050061186 ()
1203535

  • Endobronchial tube
SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
FUJI SYSTEMS CORPORATION
#35
In Commercial Distribution

  • 14544050123980 ()
  • 04544050123983 ()
  • 04544050083935 ()
1203635

  • Endobronchial tube
SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
FUJI SYSTEMS CORPORATION
#35
In Commercial Distribution

  • 14544050123942 ()
  • 04544050123945 ()
  • 04544050061186 ()
1203535

  • Endobronchial tube
SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
FUJI SYSTEMS CORPORATION
#35
In Commercial Distribution

  • 04544050083935 ()
1203635

  • Endobronchial tube
MANI CARBIDE BURS
MANI, INC.
35
In Commercial Distribution

  • 74546951534423 ()
  • 04546951534424 ()


  • Carbide dental bur, reusable
Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware does not give the possibility to the end user of any interference in the device operating parameters and records of carried out sterilization or tests.
Enbio Group AG
35
In Commercial Distribution

  • 07629999978836 ()


  • Steam sterilizer
No Description
Directa AB
35
In Commercial Distribution

  • 17310236092350 ()
609235

  • Preformed dental crown, temporary
CRYOTHERAPY KIT, TRTMT
MCKESSON MEDICAL-SURGICAL INC.
35
In Commercial Distribution

  • 20612479193998 ()


  • General cryosurgical system, cryogen gas, mechanical
Miller #35
Zoll-Dental
BF-35
In Commercial Distribution

  • 00840105200581 ()


  • Bone file/rasp, manual, reusable
Composite #35
Zoll-Dental
COMP-35
In Commercial Distribution

  • 00840105201052 ()


  • Dental spatula, reusable
#34/35
Zoll-Dental
OPAF-34/35
In Commercial Distribution

  • 00840105206064 ()


  • Margin finishing dental file/rasp, reusable
Elevator #35
HENRY SCHEIN, INC.
1000518
In Commercial Distribution

  • 00304040043905 ()
1000518

  • Periosteal elevator, reusable
SHUNTASSISTANT 35
Christoph Miethke GmbH & Co. KG
FV254T
In Commercial Distribution

  • 04041906113506 ()
FV254T

  • Cerebrospinal fluid shunt valve
EXCAVATOR 35
A. TITAN INSTRUMENTS, INC.
EXC 35
In Commercial Distribution

  • 00841685109066 ()


  • Dental excavator, reusable
HYH,-,-,-,-,35
O&M HALYARD, INC.
46828
In Commercial Distribution

  • 30680651468285 ()
  • 20680651468288 ()
  • 90680651468287 ()
46828

  • Surgical/medical respirator, non-antimicrobial, single-use
The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths: • AIR Open Head Neck Posterior 9ch • AIR Open Neck Chest Anterior 7ch • AIR Open Head Anterior 16ch The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner).
NEOCOIL, LLC
26
In Commercial Distribution

  • 00850028932261 ()
NC139201

  • MRI system coil, radio-frequency
These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
NEOCOIL, LLC
26
In Commercial Distribution

  • 00856181003268 ()


  • MRI system coil, radio-frequency
No Description
Roland Consult Stasche & Finger GmbH
26
In Commercial Distribution

  • 04260157780262 ()


  • Electroretinograph
  • Electrooculograph
Root elevator 2.5 mm H-Type B1
devemed GmbH
26
In Commercial Distribution

  • 04061644003372 ()


  • Dental elevator, tooth/root
KIATO PLUS Sterile Stainless Steel Surgical Blade box of 100 size 26. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
26
In Commercial Distribution

  • 28902895181337 ()
  • 08902895181333 ()
18133

  • Manual scalpel blade, single-use
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