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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Pre-Filled Container with Click Close Lid: Tite-Rite, 20mL (0.67oz), PP, Filled with 10mL of 10% Neutral Buffered Formalin, Attached Hazard Label, 24/Box, 4 Boxes/Unit
GLOBE SCIENTIFIC INC.
6518FL
In Commercial Distribution

  • 00840095608213 ()
  • 00840095612005 ()


  • General tissue specimen container IVD, formal saline
Seamless Viral Barrier End, Polyurethane, 1.18"D Tapered to 4"W x 24"L, Non-sterile, Pre-Gelled Extended Field Ultrasound Probe & Cord Cover, Vaginal/Rectal, Rolled, Individually Wrapped
SHEATHING TECHNOLOGIES, INC.
50001-77244
In Commercial Distribution

  • 20842418102662 ()
  • 10842418102665 ()
  • 00842418102668 ()


  • Body-orifice ultrasound imaging transducer cover, basic, non-sterile
  • Body-surface ultrasound imaging transducer cover
  • Skin topical coupling gel
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
Pre-Filled Container with Click Close Lid: Tite-Rite, 90mL (3oz), Wide Mouth, PP, Filled with 45mL of 10% Neutral Buffered Formalin, Attached Hazard Label, 24/Box, 4 Boxes/Unit
GLOBE SCIENTIFIC INC.
6525FL
In Commercial Distribution

  • 00840095608268 ()
  • 00840095612043 ()


  • General tissue specimen container IVD, formal saline
Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016047 ()
SSPR1-24

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Self-Expanding Stent
BOSTON SCIENTIFIC CORPORATION
M001712010
In Commercial Distribution

  • 08714729345596 ()

  • 24 mm Stent Length
  • 135 cm Effective Length
  • 6 mm Stent Diameter
M001712010

  • Iliac artery stent, bare-metal
Self-Expanding Stent
BOSTON SCIENTIFIC CORPORATION
M001712000
In Commercial Distribution

  • 08714729345589 ()

  • 6 mm Stent Diameter
  • 75 cm Effective Length
  • 24 mm Stent Length
M001712000

  • Iliac artery stent, bare-metal
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210324
Not in Commercial Distribution

  • M2482103241 ()
  • 10381780065760 ()

  • 3.6 mm dia x 28 mm L; leading screw 24 mm L
210324

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210320
Not in Commercial Distribution

  • M2482103201 ()
  • 10381780065746 ()

  • 3.6 mm dia x 24 mm L; leading screw 20 mm L
210320

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-IL246
In Commercial Distribution

  • 20842418103669 ()
  • 10842418103662 ()
  • 00842418103665 ()


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