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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Osteotome, Offset, Bone Blade 4.0mm Green
Suncoast Dental, Inc
OsteoZ Offset BB 4.0
In Commercial Distribution

  • 00083208224010 ()

  • Width of blade 4.0mm
OsteoZ Offset BB 4.0

  • Dental osteotome
Osteotome, Offset, Bone Blade 10.0mm Green
Suncoast Dental, Inc
OsteoZ Offset BB 10.0
In Commercial Distribution

  • 00083208221019 ()

  • Width of blade 10.0mm
OsteoZ Offset BB 10.0

  • Dental osteotome
Alternating Pressure, Low Air Loss, Battery Backup, Universal Mattress System, 36" x 84" x 8"~10".
KAP MEDICAL
Advanced Wave BB UMS
In Commercial Distribution

  • 00817012031096 ()
Advanced Wave BB UMS

  • Low-air-loss bed
Alternating Pressure, Low Air Loss, Battery Backup, Mattress System, 36" x 84" x 8".
KAP MEDICAL
Advanced Wave BB 84
In Commercial Distribution

  • 00817012031089 ()
Advanced Wave BB 84

  • Low-air-loss bed
Rotation, Low Air Loss, Battery Backup, Mattress System, 48 "x 80" x 10".
KAP MEDICAL
T-Wave BB MS 48
In Commercial Distribution

  • 00817012031065 ()
T-Wave BB MS 48

  • Low-air-loss bed
Rotation, Low Air Loss, Battery Backup, Mattress System, 36" x 84" x 10".
KAP MEDICAL
T-Wave BB MS 84
In Commercial Distribution

  • 00817012031058 ()
T-Wave BB MS 84

  • Low-air-loss bed
Alternating Pressure, Low Air Loss, Battery Backup, Width and Length Expansion, Mattress System, 36"~42"~48" x 80"~85"~90" x 10".
KAP MEDICAL
Advanced Wave BB XMS
In Commercial Distribution

  • 00817012031041 ()
Advanced Wave BB XMS

  • Low-air-loss bed
Alternating Pressure, On-Demand Low Air Loss, Battery Backup, Universal Mattress System, 36"x 86"x 9"
KAP MEDICAL
Comfort Wave BB UMS
In Commercial Distribution

  • 00817012031003 ()
Comfort Wave BB UMS

  • Low-air-loss bed
Pediatric, Pulsating, Battery Backup, Mattress System, 60"x30"x6".
KAP MEDICAL
Pediatric Wave BB MS
In Commercial Distribution

  • 00817012030730 ()
Pediatric Wave BB MS

  • Low-air-loss bed
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
54303-29
In Commercial Distribution

  • 10810929043524 ()
  • 00810929043527 ()


  • Medical device cleaning agent
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
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: Large
HIDRAMED SOLUTIONS LIMITED
GBB001-03
In Commercial Distribution

  • 05391535510306 ()


  • Non-adhesive device retention bandage
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: Medium
HIDRAMED SOLUTIONS LIMITED
GBB001-02
In Commercial Distribution

  • 05391535510290 ()


  • Non-adhesive device retention bandage
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: Small
HIDRAMED SOLUTIONS LIMITED
GBB001-01
In Commercial Distribution

  • 05391535510283 ()


  • Non-adhesive device retention bandage
The HidraWear BB Men’s Boxer Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Men’s Boxer 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 briefs 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 Extra Large
HIDRAMED SOLUTIONS LIMITED
GBB002-05
In Commercial Distribution

  • 05391535510429 ()


  • Non-adhesive device retention bandage
The HidraWear BB Men’s Boxer Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Men’s Boxer 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 briefs 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
GBB002-04
In Commercial Distribution

  • 05391535510412 ()


  • Non-adhesive device retention bandage
The HidraWear BB Men’s Boxer Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Men’s Boxer 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 briefs 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: Large
HIDRAMED SOLUTIONS LIMITED
GBB002-03
In Commercial Distribution

  • 05391535510405 ()


  • Non-adhesive device retention bandage
The HidraWear BB Men’s Boxer Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Men’s Boxer 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 briefs 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: Medium
HIDRAMED SOLUTIONS LIMITED
GBB002-02
In Commercial Distribution

  • 05391535510399 ()


  • Non-adhesive device retention bandage
The HidraWear BB Men’s Boxer Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Men’s Boxer 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 briefs 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: Small
HIDRAMED SOLUTIONS LIMITED
GBB002-01
In Commercial Distribution

  • 05391535510382 ()


  • Non-adhesive device retention bandage
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 Extra Large
HIDRAMED SOLUTIONS LIMITED
GBB001-05
In Commercial Distribution

  • 05391535510320 ()


  • Non-adhesive device retention bandage
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