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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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SS GUIDE WIRE D2.8MM L200MM PACK OF 2
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800898215 ()

  • Outer Diameter: 2.8 Millimeter
99-154283

  • Orthopaedic bone wire
SS GUIDE WIRE D2.0MM L200MM PACK OF 2
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800898192 ()

  • Outer Diameter: 2.0 Millimeter
99-154281

  • Orthopaedic implant aiming/guiding block, reusable
3M™ Durapore™ Tape MC 2 X 1 1/2 YD 50 Rolls/Carton 5 Cartons/Case 1538S-2
3M COMPANY
1538S-2
In Commercial Distribution

  • 50707387075601 ()
  • 30707387075607 ()
  • 00707387075606 ()
1538S-2

  • Hypoallergenic skin adhesive tape
Seamless Viral Barrier Contoured End, Polyurethane, 2" x 2" Face to 6"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-IJ966
In Commercial Distribution

  • 20842418103621 ()
  • 10842418103624 ()
  • 00842418103627 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
Seamless Viral Barrier Contoured End, Polyurethane, 2" x 2" Face to 6"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-IJ486
In Commercial Distribution

  • 20842418103614 ()
  • 10842418103617 ()
  • 00842418103610 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (gauze), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression.
Medique Products
68999
In Commercial Distribution

  • 50347682689990 ()
  • 00347682689995 ()
68999

  • Woven gauze roll, non-sterile
The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9507-0
In Commercial Distribution

  • 00607158000069 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3082-102
In Commercial Distribution

  • 00848665039382 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3081-102
In Commercial Distribution

  • 00848665032215 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
No Description
KEELER LIMITED
1205-P-2003
In Commercial Distribution

  • 05055272712613 ()


  • Indirect binocular ophthalmoscope, line-powered
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