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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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SURGIPLUS - 74895237109122

Surgical Mask
KENPAX INTERNATIONAL LIMITED
1
In Commercial Distribution

  • 74895237109122 ()
  • 84895237109129 ()
68-8528-B

  • Surgical/medical face mask, single-use

SURGIPLUS - 74895237109115

The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. the mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile, meet ASTM F2100 LEVEL 3. The Surgical Mask is single use, three-layer, flat –folded masks with ties and nose wire. This Mask is manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mask close to the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in green and Blue. The surgical mask is sold non-sterile and are intended to be single use, disposable device.
KENPAX INTERNATIONAL LIMITED
1
In Commercial Distribution

  • 84895237109112 ()
  • 74895237109115 ()
68-8518-B

  • Surgical/medical face mask, single-use

SURGIPLUS - 74895237109016

Procedure Mask Face mask wiht earloop, Blue 178X95 cm
KENPAX INTERNATIONAL LIMITED
1
In Commercial Distribution

  • 84895237109013 ()
  • 74895237109016 ()
68-8600-B

  • Surgical/medical face mask, single-use

Dukal - 70665973010372

Level 2 Face Mask with Earloop BLUE
Dukal LLC
CM-101
Not in Commercial Distribution

  • 60665973010375 ()
  • 70665973010372 ()
  • 00665973010373 ()
CM-101

  • Surgical/medical face mask, non-antimicrobial, single-use

V&Q - 06970272170036

Non Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
V & Q MANUFACTURING CORPORATION
VQN0185B
In Commercial Distribution

  • 06970272170043 ()
  • 06970272170036 ()


  • Surgical/medical face mask, single-use

Splash Shield Lite - 00781963454221

Sold as box of 40
BERKLEY MEDICAL RESOURCES, INC.
4542BM
In Commercial Distribution

  • 00781963454221 ()


  • Face splash shield, single-use

Splash Shield Lite - 00781963454115

Sold as box of 40
BERKLEY MEDICAL RESOURCES, INC.
4541LBU
In Commercial Distribution

  • 00781963454115 ()


  • Face splash shield, single-use

Splash Shield Lite - 00781963454108

Sold as box of 40
BERKLEY MEDICAL RESOURCES, INC.
4541SBU
In Commercial Distribution

  • 00781963454108 ()


  • Face splash shield, single-use

Splash Shield Lite - 00781963454078

Sold as box of 40
BERKLEY MEDICAL RESOURCES, INC.
4540LBMU
In Commercial Distribution

  • 00781963454078 ()


  • Face splash shield, single-use

Splash Shield Lite - 00781963454023

Sold as box of 40
BERKLEY MEDICAL RESOURCES, INC.
4540SBMU
In Commercial Distribution

  • 00781963454023 ()


  • Face splash shield, single-use
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