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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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TiNano - B5211088241008130

ECHO Lumbar Interbody Fusion System, 24mm x 10mm x 8 degrees x 13mm
AURORA SPINE, INC.
ECHO
In Commercial Distribution

  • B5211088241008130 ()

  • Height: 13 Millimeter
  • Angle: 8 degree
  • Width: 10 Millimeter
  • Length: 24 Millimeter
108-82410-0813

  • Polymeric spinal fusion cage, sterile

TiNano - B5211088241008120

ECHO Lumbar Interbody Fusion System, 24mm x 10mm x 8 degrees x 12mm
AURORA SPINE, INC.
ECHO
In Commercial Distribution

  • B5211088241008120 ()

  • Height: 12 Millimeter
  • Angle: 8 degree
  • Width: 10 Millimeter
  • Length: 24 Millimeter
108-82410-0812

  • Polymeric spinal fusion cage, sterile

TiNano - B5211088241008110

ECHO Lumbar Interbody Fusion System, 24mm x 10mm x 8 degrees x 11mm
AURORA SPINE, INC.
ECHO
In Commercial Distribution

  • B5211088241008110 ()

  • Height: 11 Millimeter
  • Angle: 8 degree
  • Width: 10 Millimeter
  • Length: 24 Millimeter
108-82410-0811

  • Polymeric spinal fusion cage, sterile

Soft-Release-ST - 08809220580413

Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
SOOIL DEVELOPMENT CO.,LTD
SR112
In Commercial Distribution

  • 08809220580413 ()
  • 08809220580758 ()
  • 08809220580949 ()

  • Weight: 10.7 Gram
  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 24 Gauge
  • Length: 700 Millimeter


  • Ambulatory insulin infusion pump, electronic

Soft-Release-ST - 08809220580406

Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
SOOIL DEVELOPMENT CO.,LTD
SR102
In Commercial Distribution

  • 08809220580406 ()
  • 08809220580741 ()
  • 08809220580932 ()

  • Weight: 10.7 Gram
  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 24 Gauge
  • Length: 700 Millimeter


  • Ambulatory insulin infusion pump, electronic

Urocare® Fabric Leg Strap with Velcro® Fasteners, Sport sml/MED 15" to 24" DIA - 00792293063427

STRAP, FABRIC, SPORT, LEG BAG, LATEX-FREE, VELCRO FASTENERS, SMALL, MEDIUM, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9516, #9510, #8516 and #8510. 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/latex straps. Long strap ties can be easily grasped and slipped through the strap loops of the leg bags. The self-gripping fasteners 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. * BAGS MUST HAVE STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6342
In Commercial Distribution

  • 10792293063424 ()
  • 00792293063427 ()

  • Can hold up to a 16 fl. oz. (500 mL.) leg bag
  • 2" (5cm) Wide, Fits: 14" ~ 24" DIA. (36cm x 61cm Ø)
  • Weight: 0.04 Pound
6342

  • Open-ended wearable urine collection bag, non-sterile

FilteredFlo® Cardiac Blanket - 20613031825425

Thermal Regulating System
Gentherm Medical, LLC
542
In Commercial Distribution

  • 20613031825425 ()
  • 10613031825428 ()

  • Width: 50.0 Inch
  • Length: 72.0 Inch
  • Weight: 0.7 Pound
82542

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile

MediChoice - 10885632108280

Shower Chair Transport Aluminum Frame Removable Nylon Backrest Overall 21.5 Wide X 24 Deep X 39 High Seat Area 14 Wide X 16.5 Deep X 22 High 5 Inch Locking Casters 250-pound Evenly Distributed Weight Capacity Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
BTH310
In Commercial Distribution

  • 10885632108280 ()


  • Transport wheelchair, non-collapsible

NDI Passive Spheres - 00805832030023

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 12 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 24 spheres.
Northern Digital Inc
8800967
In Commercial Distribution

  • 20805832030027 ()
  • 00805832030023 ()
8800967

  • Imaging lesion localization marker, external, single-use

Urocare® Universal Fabric Leg Bag Straps with Velcro® Closue (Set of 2) - 00792293063908

STRAP, LEG BAG, LATEX-FREE, VELCRO, UNIVERSAL, REUSABLE For use with most vinyl disposable or latex reusable leg bags. They are an economical alternative to the standard latex rubber straps packaged with most urine collection bags. An elastic/cotton & body construction allows the self-gripping fastener to attach itself along the length of the strap making it fully adjustable to individual requirements providing a safe, secure hold with a comfortable fit. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. Set Contains: 2 Universal Leg straps and Illustrated Use and Care Instructions. * STRAPS NOT SOLD SEPARATELY ** BAGS MUST HAVE STRAP LOOPS/EYELETS FOR STRAPS TO PASS THROUGH
UROCARE PRODUCTS, INC.
6390
In Commercial Distribution

  • 10792293063905 ()
  • 00792293063908 ()

  • Weight: 0.06 Pound
  • Fits: 8" ~ 24" DIA. (20cm ~ 61cm Ø)
  • Universal, One size fits all Suitable for 44 fl. oz. (1,3 L) leg bags or smaller.
6390

  • Open-ended wearable urine collection bag, non-sterile
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