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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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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
Polyurethane, 6"W x 72"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-726
In Commercial Distribution

  • 20842418103324 ()
  • 10842418103327 ()
  • 00842418103320 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
Polyurethane, 5"W x 72"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-725
In Commercial Distribution

  • 20842418103317 ()
  • 10842418103310 ()
  • 00842418103313 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 4"W x 72"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Folded
SHEATHING TECHNOLOGIES, INC.
5-724
In Commercial Distribution

  • 20842418103300 ()
  • 10842418103303 ()
  • 00842418103306 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
Isoprene, 1.18"D x 11.81"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long
SHEATHING TECHNOLOGIES, INC.
5-70340
In Commercial Distribution

  • 20842418103294 ()
  • 10842418103297 ()
  • 00842418103290 ()


  • Body-orifice ultrasound imaging transducer cover, basic
  • Topical coupling gel, sterile
Polyurethane, 6"W x 58"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-586
In Commercial Distribution

  • 20842418103287 ()
  • 10842418103280 ()
  • 00842418103283 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 5.5"W x 58"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-5855
In Commercial Distribution

  • 20842418103270 ()
  • 10842418103273 ()
  • 00842418103276 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 5"W x 58"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-585
In Commercial Distribution

  • 20842418103263 ()
  • 10842418103266 ()
  • 00842418103269 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 4"W x 58"L, Non-Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-584NS
In Commercial Distribution

  • 20842418103256 ()
  • 10842418103259 ()
  • 00842418103252 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 4"W x 58"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-584
In Commercial Distribution

  • 20842418103249 ()
  • 10842418103242 ()
  • 00842418103245 ()


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