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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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The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000892 ()

  • 16x43mm
SK101643

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000885 ()

  • 16x38mm
SK101638

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000878 ()

  • 14x43mm
SK101443

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000861 ()

  • 14x38mm
SK101438

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000854 ()

  • 12x43mm
SK101243

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000847 ()

  • 12x38mm
SK101238

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000830 ()

  • 10x43mm
SK101043

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000823 ()

  • 10x38mm
SK101038

  • Polymeric spinal interbody fusion cage
No Description
ergoline GmbH
193001
In Commercial Distribution

  • 04059358002248 ()

  • Width: 90 Centimeter
  • Length: 220 Centimeter
  • Height: 180 Centimeter
  • Weight: 240 Kilogram


  • Bicycle ergometer
Gold based noble metal
ARGEN CORPORATION, THE
101920
In Commercial Distribution

  • D818101920 ()
101920

  • Dental casting noble alloy
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
No Description
BIOTRONIK SE & Co. KG
394500
In Commercial Distribution

  • 04035479131609 ()
394500

  • Cardiac pulse generator analyser cable, single-use
Sterilizer,steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640651 ()
AMS10-120-T

  • Steam sterilizer
Sterilizer,steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640644 ()
AMS10-120-W-T

  • Steam sterilizer
Sterilizer, steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640446 ()
AMS10-230-W-T

  • Steam sterilizer
Sterilizer, steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640439 ()
AMS10-230-T

  • Steam sterilizer
Neuro Guidewire with Hydrophilic Coating
Stryker Corporation
M00316330
In Commercial Distribution

  • 07613252187165 ()

  • Length: 300.0 Centimeter
  • Outer Diameter: 0.01 Inch
1633

  • Cardiac/peripheral vascular guidewire, single-use
Neuro Guidewire with Hydrophilic Coating
Stryker Corporation
M00316310
In Commercial Distribution

  • 07613252187158 ()

  • Outer Diameter: 0.01 Inch
  • Length: 200.0 Centimeter
1631

  • Cardiac/peripheral vascular guidewire, single-use
1 Tip Straight Microcatheter
Stryker Corporation
M0031351100
In Commercial Distribution

  • 07613252187035 ()

  • Length: 175.0 Centimeter
  • Distal Length: 20.0 Centimeter
135110

  • Vascular microcatheter
No Description
BIOGENEX LABORATORIES
MU201-UC
In Commercial Distribution

  • 00810119676207 ()

  • Total Volume: 1 Milliliter
MU201-UC

  • Cytokeratin IVD, antibody
InTENSity 10 Digital TENS
COMPASS HEALTH BRANDS CORP.
DI1010
In Commercial Distribution

  • 80813520011939 ()
  • 00813520011933 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
PVP 10%. 6 x 0.5 ml
Origio A/S
ART-4006-A
In Commercial Distribution

  • 20888937818868 ()
  • 00888937818888 ()


  • IVF medium
2-0 Pdo 10 X 10
Surgical Specialties México, S. de R.L. de C.V.
RA-1077Q
In Commercial Distribution

  • 10848782019202 ()
  • 00848782019205 ()

  • 2-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Focal Guide 10 x 10
Cynosure, LLC
5520-2024
In Commercial Distribution

  • 10841494100596 ()
  • 00841494100599 ()


  • Multi-modality skin surface treatment system
Gold based noble metal
ARGEN CORPORATION, THE
119200
In Commercial Distribution

  • D818119200 ()
119200

  • Dental casting noble alloy
No Description
SCIMEDX CORPORATION
I-RSV01X
In Commercial Distribution

  • 00813545026134 ()
I-RSV01X

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-MUV01X
In Commercial Distribution

  • 00813545026059 ()
I-MUV01X

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-MEA01X
In Commercial Distribution

  • 00813545026028 ()
I-MEA01X

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
AirLife DuoTherm® Neonate Dual Limb Circuit Kit
AIRLIFE
37723CE
In Commercial Distribution

  • 30889483631359 ()
  • 10889483631355 ()
37723CE

  • Oxygen administration kit
Windsor Slit Knife/ Keratome 20 gauge angled sideport. Single bevel up full handle. Sterile. Single use
CORE SURGICAL LIMITED
WK20GBU
In Commercial Distribution

  • 15060510711751 ()
  • 05060510711754 ()
WK20GBU

  • Ophthalmic knife, single-use
Post-Mortem Bag Kit (Body Bag) Adult 36"x90", Contents include: Body Bag, (3) Toe-Tags, Shroud Sheet, (4) Precaution Labels, White Vinyl Disposable gloves
Dynarex Corporation
4772
In Commercial Distribution

  • 00616784477237 ()
  • 00616784477213 ()


  • Cadaver bag
Mermaid Medical® Guidewire .035” x 150 cm, 3.5 cm (Straight Tip)
TECHDEVICE CORPORATION
G60235150
In Commercial Distribution

  • 00850758007048 ()
  • 20850758007042 ()

  • 3.5 Centimeter Tip (Straight)
  • Outer Diameter: 0.035 Inch
  • Length: 150 Centimeter
G60235150

  • Peripheral vascular guidewire, manual
No Description
Terumo Cardiovascular Systems Corporation
76940
In Commercial Distribution

  • 50699753509455 ()
  • 00699753509450 ()


  • Cardiopulmonary bypass system blood tubing set
VST Mini Blue, sterile, 0.075” x 18” / 0.2 cm x 46 cm
Batrik Medical Manufacturing Inc
VL2202
In Commercial Distribution

  • 00690521023314 ()
  • 00690521023208 ()
VL2202

  • Surgical vessel loop
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 08055182872367 ()
  • 08055182872343 ()
  • 18055182872364 ()
$92070-10

  • Plazomicin minimum inhibitory concentration (MIC) IVD
PF BLACK NITRILE EXAM GLOVE, M
MCKESSON MEDICAL-SURGICAL INC.
27-74
Not in Commercial Distribution

  • 00815555025091 ()
  • 00815555025084 ()
  • 00815555025152 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Coccyx Cushion, 18x16x3 Memory Foam
COMPASS HEALTH BRANDS CORP.
COC-18
In Commercial Distribution

  • 80092237604270 ()
  • 00815067043637 ()


  • Soft-rubber chair cushion
  • Wheelchair seat cushion
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.040", Singles
INVOTEC INTERNATIONAL, INC.
20-10680S
In Commercial Distribution

  • 10818501021045 ()
  • 00818501021048 ()
20-10680S

  • Intranasal splint, non-biodegradable
Invotec Tympanostomy Tube, Shepard Grommet, ID 1.02mm, FLPL
INVOTEC INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10818501020307 ()
  • 00818501020300 ()
23-40120

  • Tympanostomy tube
BLUE NITRILE EXAM POWDER FREE GLOVE - X-SMALL (Case) 1/10/100
CLEAN SAFETY INC.
CS4300
In Commercial Distribution

  • 00859116003944 ()
  • 10859116003941 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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