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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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The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-AT03
In Commercial Distribution

  • 05060652910114 ()
SWF-AT03

  • Intraoperative gamma radiation detection system probe cover
The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-AT02
In Commercial Distribution

  • 05060652910091 ()
SWF-AT02

  • Intraoperative gamma radiation detection system probe cover
Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962
HEPRO.US INC.
Hepro.usTSC
In Commercial Distribution

  • 00850578007389 ()
  • 85057800738902 ()


  • Glucose monitoring system IVD, home-use
Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumbent exposure and is covered to reinforce the strength.
FUJIFILM CORPORATION
DR1836 SE PROTECTIVE COVER E
In Commercial Distribution

  • 04547410483437 ()

  • 470x860x25mm


  • Stationary basic diagnostic x-ray system, digital
The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.
Wallac Oy
1296-0050
In Commercial Distribution

  • 06438147297726 ()
1296-0050

  • Laboratory shaker IVD
The Universal Legholder is contoured and padded for comfortable leg support, and is mounted on a ball joint for positioning flexibility.
STERIS CORPORATION
BF266
In Commercial Distribution

  • 00724995156985 ()
BF266

  • Leg procedure positioner
The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This product is used exclusively for our loaner program.
US Endoscopy
00711579
In Commercial Distribution

00711579

  • Surgical irrigation pump
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the single microplate product.
IMMUCOR, INC.
0066246
In Commercial Distribution

  • 10888234001270 ()
0066246

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. 30 Part B Carpules, bagged.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-028 N
In Commercial Distribution

  • D801SP67028N1 ()
67-028

  • Dentine adhesive
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008203 ()
  • 08054083008202 ()


  • Personal device holder, reusable
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