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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HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGE A simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals.
UROCARE PRODUCTS, INC.
6384
In Commercial Distribution

  • 00792293063847 ()

  • Can hold up to a 26 fl. oz. (800 mL.) leg bag
  • Upper Thigh: 24" DIA. (61cm Ø) Lower Thigh: 19.25" DIA. (49cm Ø)
  • Weight: 0.20 Pound
6384

  • Open-ended wearable urine collection bag, non-sterile
The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation of the hand and foot following trauma or osteotomy. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6DIGITIMP
Not in Commercial Distribution

  • M268TI6DIGITIMP1 ()
  • 10381780074304 ()
TI6DIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 – 50mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPDIGITIMP
Not in Commercial Distribution

  • M268CAPDIGITIMP1 ()
  • 10381780064503 ()
CAPDIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Assay when processing 24–36 samples. The assay detects mutations in the protein coding regions and intron/exon boundaries of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, including two large deletions and two-deep intronic mutations. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072974
In Commercial Distribution

  • 00816270020385 ()
20072974

  • Cystic fibrosis IVD, kit, multiplex
The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072975
In Commercial Distribution

  • 00816270020378 ()
20072975

  • Cystic fibrosis IVD, kit, multiplex
STRAP, LEG BAG, LATEX-FREE, VELCRO, BUTTONS, REUSABLE Fits most vinyl disposable urinary leg bags and offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber straps. Large buttons can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fastener can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. Set Contains: 1 Upper leg strap #6374, 1 Lower leg strap #6375 and Illustrated Use and Care Instructions. * STRAPS NOT SOLD SEPARATELY ** BAGS MUST HAVE EYELETS FOR BUTTONS TO PASS THROUGH
UROCARE PRODUCTS, INC.
6380
In Commercial Distribution

  • 10792293063806 ()
  • 00792293063809 ()

  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
  • Upper Strap: 2" (5cm) Wide, Fits up to 24" DIA. (61cm Ø), Lower Strap: 2" (5cm) Wide, Fits up to 18" DIA. (45cm Ø)
  • Weight: 0.10 Pound
6380

  • Open-ended wearable urine collection bag, non-sterile
Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Clearmask, LLC
v1.0
In Commercial Distribution

  • 10860005106025 ()
  • 00860005106028 ()
  • 20860005106022 ()
  • 00860005106035 ()


  • Surgical/medical face mask, single-use
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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