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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Earloop Mask - White ASTM Level 2
Plastcare USA
MWH2
In Commercial Distribution

  • D915MWH22 ()
  • D915MWH21 ()
  • D915MWH20 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Earloop Mask - Pink ASTM Level 2
Plastcare USA
MPI2
In Commercial Distribution

  • D915MPI22 ()
  • D915MPI21 ()
  • D915MPI20 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Earloop Mask - Blue ASTM Level 2
Plastcare USA
MBL2
In Commercial Distribution

  • D915MBL22 ()
  • D915MBL21 ()
  • D915MBL20 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Earloop Mask - Black ASTM Level 2
Plastcare USA
MBK2
In Commercial Distribution

  • D915MBK22 ()
  • D915MBK21 ()
  • D915MBK20 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Earloop procedure mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 1, non-sterile, case of 300 ea
Strong Medical Partners LLC
5301
In Commercial Distribution

  • 10853927007730 ()
  • 00853927007733 ()
5301

  • Surgical/medical face mask, single-use
Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Clearmask, LLC
v1.0
In Commercial Distribution

  • 10860005106025 ()
  • 00860005106028 ()
  • 20860005106022 ()
  • 00860005106035 ()


  • Surgical/medical face mask, single-use
Premium-PPE Amerishield AirMax Procedure Mask, ASTM Level 3, 4-Ply Adult Blue, Inner Carton of 50 Masks, K211275
Premiumestore, LLC
PPE-M-AS-SUR-S
In Commercial Distribution

  • 00860004941927 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Inner Carton of 50 Masks, K211520
Premiumestore, LLC
PPE-M-AS-SUR-LVL2-S
In Commercial Distribution

  • 00860004941910 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
N P Medical Inc.
6412107
In Commercial Distribution

  • 00860004362913 ()

  • Length: 17.5 Centimeter
  • Width: 9.5 Centimeter
6412107

  • Surgical/medical face mask, single-use
The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
N P Medical Inc.
6409996
In Commercial Distribution

  • 00860004362906 ()

  • Length: 17.5 Centimeter
  • Width: 9.5 Centimeter
6409996

  • Surgical/medical face mask, single-use
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