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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Alternating Pressure, Low Air Loss, Battery Backup, Variable Length Extension, Mattress System, 36" x 80"~85"~90" x 8".
KAP MEDICAL
Advanced Wave BB VL MS
In Commercial Distribution

  • 00817012030754 ()
Advanced Wave BB VL MS

  • Low-air-loss bed
Phosphate Buffered Saline, 10g
MARDX DIAGNOSTICS, INC.
90-1607
In Commercial Distribution

  • 05391516747585 ()
90-1607

  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
  • Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
ORTHOCORD Violet Braided Composite Suture BB 17 mm 3/8c, Taper Point N=1 Meets U.S.P. and E.P. except for diameter 3-0 (2 metric), 18 Inches (45 cm)
Medos International Sàrl
223125
In Commercial Distribution

  • 20886705022936 ()
  • 10886705022939 ()
223125

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
ORTHOCORD Violet Braided Composite Suture BB 17 mm 3/8c, Taper Point N=1 Meets U.S.P. and E.P. except for diameter 2-0 (3 metric), 18 Inches (45 cm)
Medos International Sàrl
223126
In Commercial Distribution

  • 20886705022912 ()
  • 10886705022915 ()
223126

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Black Belt II Tilting Arm Retractor Basic Set Consists of the Following: 1x 7320-10U - Black Belt II Tilting Arm Retractor Frame Right, 1x 7320-20U - Black Belt II Tilting Arm Retractor Frame Left, 1x 7320-30U - Black Belt II Tilting Arm Retractor Frame Offset, 2x 7320-40 - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34 - Black Belt Blade Pronged 34mm, 2x 7322-40 - Black Belt Blade Pronged 40mm, 2x 7322-45 - Black Belt Blade Pronged 45mm, 2x 7322-50 - Black Belt Blade Pronged 50mm, 2x 7322-55 - Black Belt Blade Pronged 55mm, 2x 7322-60 - Black Belt Blade Pronged 60mm, 2x 7322-70 - Black Belt Blade Pronged 70mm, 2x 7324-34 - Black Belt Blade Blunt 34mm, 2x 7324-40 - Black Belt Blade Blunt 40mm, 2x 7324-45 - Black Belt Blade Blunt 45mm, 2x 7324-50 - Black Belt Blade Blunt 50mm, 2x 7324-55 - Black Belt Blade Blunt 55mm, 2x 7324-60 - Black Belt Blade Blunt 60mm, 2x 7324-70 - Black Belt Blade Blunt 70mm, 4x 7326-40 - BB Two-Level Blade Pronged 40mm, 4x 7326-47 - BB Two-Level Blade Pronged 47mm, 4x 7326-55 - BB Two-Level Blade Pronged 55mm, 2x 7328-40 - BB Two-Level Blade Blunt 40mm, 2x 7328-47 - BB Two-Level Blade Blunt 47mm, 2x 7328-55 - BB Two-Level Blade Blunt 55mm, 1x 7320-90 - Black Belt Retractor Instrument Case
KOROS U.S.A., INC.
7320-00U
In Commercial Distribution

  • 00840199501816 ()
  • 10840199501813 ()
7320-00U

  • Self-retaining surgical retractor, reusable
ORTHOCORD Violet Braided Composite Suture BB 17 mm 3/8c, Taper Point N=1 Meets U.S.P. and E.P. except for diameter 4-0 (1.5 metric), 20 Inches Loop (50 cm)
Medos International Sàrl
223121
In Commercial Distribution

  • 20886705022967 ()
  • 10886705022960 ()
223121

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Black Belt Cervical Retractor Extended Set Consists of the Following: 1x 7320-22 - Korpectomy Retractor frame Right, 1x 7320-20 - Retractor Frame Left, 1x 7320-30 - Retractor Frame Offset, 2x 7320-40 - Blade Inserting Clamp, 1x 7321-10 - Micro Discectomy Adaptor, 1x 7321-20 - Spike Blade 70mm, 1x 7321-30 - T-Shape Blade 70mm, 1x 7321-40 - Inner Spine Ligament Blade 70mm, 2x 7322-34 - Black Belt Blade Pronged 34mm, 2x 7322-40 - Black Belt Blade Pronged 40mm, 2x 7322-45 - Black Belt Blade Pronged 45mm, 2x 7322-50 - Black Belt Blade Pronged 50mm, 2x 7322-55 - Black Belt Blade Pronged 55mm, 2x 7322-60 - Black Belt Blade Pronged 60mm, 2x 7322-70 - Black Belt Blade Pronged 70mm, 2x 7324-34 - Black Belt Blade Blunt 34mm, 2x 7324-40 - Black Belt Blade Blunt 40mm, 2x 7324-45 - Black Belt Blade Blunt 45mm, 2x 7324-50 - Black Belt Blade Blunt 50mm, 2x 7324-55 - Black Belt Blade Blunt 55mm, 2x 7324-60 - Black Belt Blade Blunt 60mm, 2x 7324-70 - Black Belt Blade Blunt 70mm, 4x 7326-40 - BB Two-Level Blade Pronged 40mm, 4x 7326-47 - BB Two-Level Blade Pronged 47mm, 4x 7326-55 - BB Two-Level Blade Pronged 55mm, 2x 7328-40 - BB Two-Level Blade Blunt 40mm, 2x 7328-47 - BB Two-Level Blade Blunt 47mm, 2x 7328-55 - BB Two-Level Blade Blunt 55mm, 1x 7322-85 - Black Belt Blade Pronged 85mm, 1x 7322-75 - Extra Long Retractor Rack 15cm, 1x 7320-90 - Sterilizing Instrument Case with Silicone Pads
KOROS U.S.A., INC.
7320-05
In Commercial Distribution

  • 00840199501823 ()
  • 10840199501820 ()
7320-05

  • Self-retaining surgical retractor, reusable
Clear View Black Belt II Ti Tilting Arm Retractor Basic Set Consists of the Following: 1x 7320-10TU - Black Belt II Ti Tilting Arm Retractor Frame Right, 1x 7320-20TU - Black Belt II Ti Tilting Arm Retractor Frame Left, 1x 7320-30TU - Black Belt II Ti Tilting Arm Retractor Frame Offset, 2x 7320-40T - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34T - Black Belt Blade Ti Pronged 34mm, 2x 7322-40T - Black Belt Blade Ti Pronged 40mm, 2x 7322-45T - Black Belt Blade Ti Pronged 45mm, 2x 7322-50T - Black Belt Blade Ti Pronged 50mm, 2x 7322-55T - Black Belt Blade Ti Pronged 55mm, 2x 7322-60T - Black Belt Blade Ti Pronged 60mm, 2x 7322-70T - Black Belt Blade Ti Pronged 70mm, 2x 7324-34T - Black Belt Blade Ti Blunt 34mm, 2x 7324-40T - Black Belt Blade Ti Blunt 40mm, 2x 7324-45T - Black Belt Blade Ti Blunt 45mm, 2x 7324-50T - Black Belt Blade Ti Blunt 50mm, 2x 7324-55T - Black Belt Blade Ti Blunt 55mm, 2x 7324-60T - Black Belt Blade Ti Blunt 60mm, 2x 7324-70T - Black Belt Blade Ti Blunt 70mm, 4x 7326-40T - BB Two-Level Blade Ti Pronged 40mm, 4x 7326-47T - BB Two-Level Blade Ti Pronged 47mm, 4x 7326-55T - BB Two-Level Blade Ti Pronged 55mm, 2x 7328-40T - BB Two-Level Blade Ti Blunt 40mm, 2x 7328-47T - BB Two-Level Blade Ti Blunt 47mm, 2x 7328-55T - BB Two-Level Blade Ti Blunt 55mm, 1x 7320-90 - Black Belt Retractor Instrument Case
KOROS U.S.A., INC.
7320-00TU
In Commercial Distribution

  • 00840199501809 ()
  • 10840199501806 ()
7320-00TU

  • Self-retaining surgical retractor, reusable
Black Belt II Tilting Arm Retractor Basic Set All Titanium, Consists of the Following: 1x 7320-10TU - Black Belt II Ti Tilting Arm Retractor Frame Right, 1x 7320-20TU - Black Belt II Ti Tilting Arm Retractor Frame Left, 1x 7320-30TU - Black Belt II Ti Tilting Arm Retractor Frame Offset, 2x 7320-40M - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34M - Black Belt Ti Blade Pronged 34mm, 2x 7322-40M - Black Belt Ti Blade Pronged 40mm, 2x 7322-45M - Black Belt Ti Blade Pronged 45mm, 2x 7322-50M - Black Belt Ti Blade Pronged 50mm, 2x 7322-55M - Black Belt Ti Blade Pronged 55mm, 2x 7322-60M - Black Belt Ti Blade Pronged 60mm, 2x 7322-70M - Black Belt Ti Blade Pronged 70mm, 2x 7324-34M - Black Belt Ti Blade Blunt 34mm, 2x 7324-40M - Black Belt Ti Blade Blunt 40mm, 2x 7324-45M - Black Belt Ti Blade Blunt 45mm, 2x 7324-50M - Black Belt Ti Blade Blunt 50mm, 2x 7324-55M - Black Belt Ti Blade Blunt 55mm, 2x 7324-60M - Black Belt Ti Blade Blunt 60mm, 2x 7324-70M - Black Belt Ti Blade Blunt 70mm, 2x 7326-40M - BB Two-Level Ti Blade Pronged 40mm, 2x 7326-47M - BB Two-Level Ti Blade Pronged 47mm, 2x 7326-55M - BB Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - BB Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - BB Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - BB Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Black Belt Retractor Instrument Case
KOROS U.S.A., INC.
7320-00MU
In Commercial Distribution

  • 00840199501786 ()
  • 10840199501783 ()
7320-00MU

  • Self-retaining surgical retractor, reusable
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GBB001-04
In Commercial Distribution

  • 05391535510313 ()


  • Non-adhesive device retention bandage
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