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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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SINGLE COMPONENT DENTAL ADHESIVE, LIGHT CURE UNO Kit: 2 x 6 mL bottles Dentastic UNO, 5 mL etch gel, 20 APPLICATOR TIPS, 50 BRUSH TIPS, BRUSH HANDLE
PULPDENT CORPORATION
UNO
In Commercial Distribution

  • D701UNO2 ()


  • Dentine adhesive
Polyurethane, 7/8"D Tapered to 4"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Vaginal/Rectal, Tapered, Rolled
SHEATHING TECHNOLOGIES, INC.
5-26484
In Commercial Distribution

  • 20842418104079 ()
  • 10842418104072 ()
  • 00842418104075 ()


  • Topical coupling gel, sterile
  • Body-orifice ultrasound imaging transducer cover, basic
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 1"D Tapered to 3"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Intraoperative, Custom Tip, Telescopically Folded
SHEATHING TECHNOLOGIES, INC.
5-961CT
In Commercial Distribution

  • 20842418103447 ()
  • 10842418103440 ()
  • 00842418103443 ()


  • Topical coupling gel, sterile
  • Body-orifice ultrasound imaging transducer cover, basic
  • Body-surface ultrasound imaging transducer cover
Polyurethane, 7/8"D Tapered to 4"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Vaginal/Rectal, Tapered, Rolled
SHEATHING TECHNOLOGIES, INC.
5-26364
In Commercial Distribution

  • 10842418102948 ()
  • 00842418102941 ()


  • Topical coupling gel, sterile
  • Body-orifice ultrasound imaging transducer cover, basic
  • Body-surface ultrasound imaging transducer cover
Seamless Viral Barrier End, Polyurethane, 1.5"W Tapered to 4.5"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-2445T
In Commercial Distribution

  • 20842418102884 ()
  • 10842418102887 ()
  • 00842418102880 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Seamless Viral Barrier Box End, Polyurethane, 1" x 2.9" Face to 4.5"W x 12"L, Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-1245
In Commercial Distribution

  • 20842418102808 ()
  • 10842418102801 ()
  • 00842418102804 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
Seamless Viral Barrier Burr End, Polyurethane, 0.5"D Tapered to 5"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-IB965
In Commercial Distribution

  • 20842418103560 ()
  • 10842418103563 ()
  • 00842418103566 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
Seamless Viral Barrier Burr End, Polyurethane, 1.2"D Tapered to 6"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-IA966
In Commercial Distribution

  • 20842418103553 ()
  • 10842418103556 ()
  • 00842418103559 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Maloney LASIK flap flipper and squeegee, 4 1/2'', vaulted shaft, 11.0mm from bend to tip, flat profile tip, rounded spatula, to lift and remove flap wrinkles, round handle
AMBLER SURGICAL CORP.
Maloney LASIK flap flipper and squeegee
In Commercial Distribution

  • 00190660101923 ()
9207E

  • Ocular hook/spatula/manipulator, reusable
Maloney LASIK flap flipper and squeegee, 4 1/2'', vaulted shaft, 11.0mm from bend to tip, flat profile tip, rounded spatula, to lift and remove flap wrinkles, flat handle
AMBLER SURGICAL CORP.
Maloney LASIK flap flipper and squeegee
In Commercial Distribution

  • 00190660101916 ()
9206E

  • Ocular hook/spatula/manipulator, reusable
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