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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 - B5211120240800080

ECHO SD Lumbar Interbody Fusion System, 24mm x 8mm x 0 degrees x 8mm
AURORA SPINE, INC.
ECHO SD
In Commercial Distribution

  • B5211120240800080 ()

  • Height: 8 Millimeter
  • Angle: 0 degree
  • Width: 8 Millimeter
  • Length: 24 Millimeter
112-02408-0008

  • Polymeric spinal fusion cage, sterile

Aurora Spine - B521112024080007UC0

ECHO SD Lumbar Interbody Fusion System, 24mm x 8mm x 0 degrees x 7mm, UNCOATED
AURORA SPINE, INC.
ECHO SD
In Commercial Distribution

  • B521112024080007UC0 ()

  • Height: 7 Millimeter
  • Angle: 0 degree
  • Width: 8 Millimeter
  • Length: 24 Millimeter
112-02408-0007-UC

  • Polymeric spinal fusion cage, sterile

TiNano - B5211120240800070

ECHO SD Lumbar Interbody Fusion System, 24mm x 8mm x 0 degrees x 7mm
AURORA SPINE, INC.
ECHO SD
In Commercial Distribution

  • B5211120240800070 ()

  • Height: 7 Millimeter
  • Angle: 0 degree
  • Width: 8 Millimeter
  • Length: 24 Millimeter
112-02408-0007

  • Polymeric spinal fusion cage, sterile

Sheathes - 10842418103334

Seamless Viral Barrier End, Polyurethane, 1.18"D Tapered to 4"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Vaginal/Rectal, Tapered, Rolled
SHEATHING TECHNOLOGIES, INC.
5-74244
In Commercial Distribution

  • 20842418103331 ()
  • 10842418103334 ()
  • 00842418103337 ()


  • Topical coupling gel, sterile
  • Body-orifice ultrasound imaging transducer cover, basic
  • Body-surface ultrasound imaging transducer cover

Sheathes3D - 10842418102740

Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
ADH-5-IL246
In Commercial Distribution

  • 20842418102747 ()
  • 10842418102740 ()
  • 00842418102743 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile

Sheathes3D - 10842418102733

Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 2.9" Face to 4.5"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
ADH-5-IL2445
In Commercial Distribution

  • 20842418102730 ()
  • 10842418102733 ()
  • 00842418102736 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, 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
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