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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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
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
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
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
Seamless Viral Barrier Box End, Polyurethane, 1" x 2.9" Face 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-IL2445
In Commercial Distribution

  • 20842418103652 ()
  • 10842418103655 ()
  • 00842418103658 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
Seamless Viral Barrier End, Polyurethane, 2.25" x 1.1" Face to 4.5"W x 24"L, Sterile, Specialty Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-80740-24
In Commercial Distribution

  • 20842418103409 ()
  • 10842418103402 ()
  • 00842418103405 ()


  • Topical coupling gel, sterile
  • Body-surface ultrasound imaging transducer cover
Novel VC, L-5, 10mm, Titanium
ALPHATEC SPINE, INC.
64305-110
In Commercial Distribution

  • 00844856009530 ()

  • Width: 24 Millimeter
  • Height: 10 Millimeter
  • Length: 38 Millimeter
  • Angle: 5 degree


  • Metallic spinal fusion cage, non-sterile
Novel VC, L-5, 8mm, Titanium
ALPHATEC SPINE, INC.
64305-108
In Commercial Distribution

  • 00844856009523 ()

  • Angle: 5 degree
  • Height: 8 Millimeter
  • Length: 38 Millimeter
  • Width: 24 Millimeter


  • Metallic spinal fusion cage, non-sterile
ALIF CAGE
CLARIANCE
42522818-S
In Commercial Distribution

  • 03700780629367 ()

  • Width: 26 Millimeter
  • Angle: 18 degree
  • Depth: 24 Millimeter
  • Height: 18 Millimeter
42522818-S

  • Polymeric spinal fusion cage, sterile
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