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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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Starlite MICS Sinskey II Lens manipulating hook, 4 5/8'', angled shaft, 10.0mm from bend to tip, 0.18mm diameter blunt stainless steel tip, titanium handle
AMBLER SURGICAL CORP.
Starlite MICS Sinskey II Lens manipulating hook
In Commercial Distribution

  • 00190660102920 ()
9310T

  • Ocular hook/spatula/manipulator, reusable
Ambler Toric irrigating IOL positioner, 5'', angled shaft, 10.0mm from bend to tip, dual irrigating ports, single hook for haptic rotation, removable tip, titanium handle
AMBLER SURGICAL CORP.
Ambler Toric irrigating IOL positioner
In Commercial Distribution

  • 00190660102098 ()
3100E

  • Ocular hook/spatula/manipulator, reusable
Grayson-Kuglen nucleus manipulator, 5 1/2'', double-ended, angled shafts, 9.0mm from bend to flat olive tip, 10.0mm from bend to push-pull tip, round handle, titanium
AMBLER SURGICAL CORP.
Grayson-Kuglen nucleus manipulator
In Commercial Distribution

  • 00190660101688 ()
9264T

  • Ocular hook/spatula/manipulator, reusable
Seamless Viral Barrier Adhesive Patch, Latex-Free, 1.5"W x 4.5"L on 3"W x 5"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel
SHEATHING TECHNOLOGIES, INC.
ADH-5-35
In Commercial Distribution

  • 20842418104307 ()
  • 10842418104300 ()
  • 00842418104303 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Seamless Viral Barrier, Polyurethane, 1.18"D x 11"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover with 5" Debris Shield, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped
SHEATHING TECHNOLOGIES, INC.
77350
In Commercial Distribution

  • 20842418104024 ()
  • 10842418104027 ()
  • 00842418104020 ()


  • Body-orifice ultrasound imaging transducer cover, basic, non-sterile
  • Skin topical coupling gel
EMT 5, Infant, Child, Adult, Large Adult, Thigh, Nylon Cuff, Orange, Latex Free, Includes: Palm Gauge, Utility Scissors, Tourniquets, Taylor Hammer, Dual Head Orange Stethoscope
BV Medical
20-182-190-L
In Commercial Distribution

  • 00845821025838 ()


  • Percussion hammer, manual, reusable
  • Limb tourniquet, manual, single-use
  • General-purpose surgical scissors, reusable
  • Hand-held examination/treatment light
  • Mechanical external stethoscope
  • Aneroid manual sphygmomanometer
Rocket Stylet 18cm ET Pro Handle
ROCKET MEDICAL PLC
R57591-ET-18
In Commercial Distribution

  • 05055270967244 ()
  • 05055270967237 ()
  • 05055270967220 ()

  • Length: 18.0 Centimeter
R57591-ET-18

  • Assisted reproduction catheter set
Rocket IPC Split Dilator 16G x 11cm
ROCKET MEDICAL PLC
R54410-16-11
In Commercial Distribution

  • 05055270963680 ()
  • 05055270942289 ()
  • 05055270920898 ()

  • Length: 11.0 Centimeter
  • Catheter Gauge: 16.0 French
R54410-16-11

  • Pleural drainage system fluid collector
Rocket Bulb Tip Trial Transfer Set 23cm
ROCKET MEDICAL PLC
R57636-00-23
In Commercial Distribution

  • 05055270936042 ()
  • 05055270914651 ()
  • 05055270957443 ()

  • Length: 23.0 Centimeter
R57636-00-23

  • Assisted reproduction catheter set
Rocket Bulb Tip Trial Transfer Set 18cm
ROCKET MEDICAL PLC
R57636-00-18
In Commercial Distribution

  • 05055270957436 ()
  • 05055270936035 ()
  • 05055270914644 ()

  • Length: 18.0 Centimeter
R57636-00-18

  • Assisted reproduction catheter set
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