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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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KE010 CMA - 20607915129327

Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTB03, 5x100 Kii SH BLD ZTHR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CTB73, 12x100 Kii SH BLD ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK205
In Commercial Distribution

  • 20607915129327 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic irrigation/aspiration cannula
  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic

KIT KE179 COLON - 20607915135816

Kit Contains: CTB73, 12x100 Kii SH BLD ZTHR 6/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTB03, 5x100 Kii SH BLD ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK280
In Commercial Distribution

  • 20607915135816 ()


  • Laparoscopic electrosurgical blunt dissector
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic

DENTSPLY Tulsa Dental Specialties - 10817417020081

HANDPIECE, DIRECT DRIVE, AC-POWERED (MICROMOTOR) Accessory to AEU-27T.
ASEPTICO, INC.
AE-250-30-T
In Commercial Distribution

  • 10817417020081 ()

  • Weight: 1 Pound
AE-250-30-T

  • Dental power tool system handpiece, line-powered

KERR - 10817417020043

HANDPIECE, DIRECT DRIVE, AC-POWERED (CONSOLE)
ASEPTICO, INC.
AEU-28KER
In Commercial Distribution

  • 10817417020043 ()

  • Weight: 8 Pound
AEU-28KER

  • Dental power tool system handpiece, line-powered

FItz-All® Fabric Leg Strap Kit with Velcro® Fasteners, Large (Set of 2) - 00792293063700

STRAP KIT, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, 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/latex straps. Long strap ties can be easily grasped and slipped through the eyelets of most all vinyl disposable 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. Set Contains: 1 Upper leg strap #6356, 1 Lower leg strap #6358 and Illustrated Use and Care Instructions. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6370
In Commercial Distribution

  • 00792293063700 ()
  • 10792293063707 ()

  • Weight: 0.12 Pound
  • Small: 2" (5cm) Wide, Fits: 13" ~ 20" DIA. (33cm x 50cm Ø), Large: 2" (5cm) Wide, Fits: 21" ~ 30" DIA. (53cm x 76cm Ø)
  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
6370

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

LAP CHOLE KIT - 30607915131013

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CY010, 5mmX35cm EPIX® LAPA DISSECT, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2394
In Commercial Distribution

  • 30607915131013 ()


  • Laparoscopic electrosurgical blunt dissector
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic

KIT KE183 COLE - 20607915135755

Kit Contains: CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTB03, 5x100 Kii SH BLD ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK268
In Commercial Distribution

  • 20607915135755 ()


  • Laparoscopic electrosurgical blunt dissector
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Spring-loaded pneumoperitoneum needle, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic

KIT KE226 COLON - 20607915133898

Kit Contains: C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CFF73, 12x100 Kii Fios ADVFIX 6/BX CFF03, 5x100 Kii Fios ADVFIX 6/BX CFF33, 11X100 Kii Fios ADVFIX 6/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CA090, DIRECT DRIVE LCA 3/BX C8702, M ALEXIS LAP SYS W/Kii Fios 5/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK253
In Commercial Distribution

  • 20607915133898 ()


  • General surgical procedure kit, non-medicated, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic electrosurgical blunt dissector
  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Ligation clip, metallic

Urocare® Fabric Leg Strap Kit with Velcro® Fasteners, Extra-Large Set of 2 - 00792293063519

STRAP KIT, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, EXTRA-LARGE, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9544, #9532, #9526, #8532, #8526 and #8518. 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. Set Contains: 1 Upper leg strap #6345, 1 Lower leg strap #6346 and Illustrated Use and Care Instructions. * BAGS MUST HAVE STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6351
In Commercial Distribution

  • 00792293063519 ()
  • 10792293063516 ()

  • Can hold up to a 44 fl. oz. (1,300 mL.) leg bag
  • Upper Strap: 3" (7.6cm) Wide, Fits: 20" ~ 26" DIA. (51cm ~ 66cm Ø), Lower Strap: 2"(5cm) Wide, Fits: 12" ~ 17" DIA. (31cm x 43cm Ø)
  • Weight: 0.12 Pound
6351

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

Vestibular First - 00860002280707

The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Vestibular First, LLC
Insight Infrared Video Goggles
In Commercial Distribution

  • 10860002280704 ()
  • 00860002280707 ()


  • Vision/eye movement analysis system
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