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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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MEBO Would Dressing - 00860005367511

The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
40mmx100mm
In Commercial Distribution

  • 00860005367511 ()
  • 10860005367518 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial

HYBENX Advanced Dental Debridement Gel - 00860004740322

HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.
Epien Medical, Inc.
109-0004
In Commercial Distribution

  • 00860004740322 ()

  • Total Volume: 1.5 Milliliter
109-0004

  • Dental mouthwash

HYBENX Advanced Dental Debridement - 00860004740315

HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.
Epien Medical, Inc.
109-0001
In Commercial Distribution

  • 00860004740315 ()

  • Total Volume: 1.5 Milliliter
109-0001

  • Dental mouthwash

Tenex Health TX® - 00857156006352

Power Cord, 220V, Europe
TENEX HEALTH, INC.
430-4024-001
In Commercial Distribution

  • 00857156006352 ()
430-4024-001

  • Ultrasonic suction system

Tenex Health TX® - 00857156006338

Inflation Cuff, 1000cc
TENEX HEALTH, INC.
557-0017-001
In Commercial Distribution

  • 00857156006338 ()
557-0017-001

  • Ultrasonic suction system

Tenex Health TX® - 00857156006321

Inflation Cuff, 500cc
TENEX HEALTH, INC.
554-1006-001
In Commercial Distribution

  • 00857156006321 ()
554-1006-001

  • Ultrasonic suction system

Tenex Health TX® - 00857156006314

Travel Case
TENEX HEALTH, INC.
551-7002-001
In Commercial Distribution

  • 00857156006314 ()
551-7002-001

  • Ultrasonic suction system

Tenex Health TX® - 00857156006307

TX System Console
TENEX HEALTH, INC.
554-0000-000
In Commercial Distribution

  • 00857156006307 ()
  • 00857156006345 ()
554-0000-000

  • Ultrasonic suction system

Tenex Health TX® - 00857156006291

TX Foot Pedal
TENEX HEALTH, INC.
554-0001-001
In Commercial Distribution

  • 00857156006291 ()
554-0001-001

  • Ultrasonic suction system

Tenex Health TX® - 00857156006277

Power Cord, 120V, USA
TENEX HEALTH, INC.
430-4023-001
In Commercial Distribution

  • 00857156006277 ()
430-4023-001

  • Ultrasonic suction system
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