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"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560).
The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."
GS Medical Co., Ltd.
1106-1445
In Commercial Distribution
- 08806378366142 ()
1106-1445
- Bone-screw internal spinal fixation system, non-sterile
The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution
- 00866489000098 ()
741743
- Nucleic acid sample preparation instrument IVD, semi-automated
The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create whole blood lysates and pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 2.0
In Commercial Distribution
- 00866489000029 ()
740807
- Pipetting system
An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma.
RANDOX LABORATORIES LIMITED
AL3801
In Commercial Distribution
- 05055273200218 ()
AL3801
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative detection of Respiratory Syncytial Virus Antigen in Nasopharyngeal specimens.
BTNX Inc
RSV-19C30
In Commercial Distribution
- 00722066001974 ()
- 00722066004265 ()
RSV-19C30
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid
JackBox with 64 Common Reference Inputs, with 6 of them to be switched to Bipolar, to be used with CERVELLO 64 Series Headboxes
BLACKROCK NEUROMED, LLC
7524
In Commercial Distribution
- 00850154007055 ()
7524
- Electroencephalography telemetric monitoring system
MYCOFAST US has been designed for the detection, enumeration and identification of Ureaplasma urealyticum (U.u.) and Mycoplasma hominis (M.h.) in various clinical sspecimens.
ELITECH MICROBIO
00050
In Commercial Distribution
- 03661540100031 ()
00050
- Mycoplasma species broth culture medium IVD
The device is the washing (with or without ultrasounds) of surgical instruments, equipment and objects normally used in hospital wards and medical studios.
STEELCO SPA
US 100 XL
In Commercial Distribution
- 08058341871393 ()
US 100 XL
- Surgical utensil washer/disinfector
External fixation kit composed of:
- Knee fixator (1 pc);
- Clamp with bone screw holder (4 pcs);
- Guide wire (1 pc);
- Pin (1 pc).
CITIEFFE SRL
Knee external fixator
In Commercial Distribution
- 08032909623792 ()
F4-2460
- External orthopaedic fixation system, single-use, sterile
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution
- 00814695022892 ()
5341025D
- HLA class I & II antigen tissue typing IVD, kit, multiplex