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 Procedure Mask, blue, contains forming nosepiece, free of metal components, MRI compatible, ASTM F2100 Level 2
Strong Medical Partners LLC
5303
In Commercial Distribution

  • 10850005354366 ()
  • 00850005354369 ()
5303

  • Surgical/medical face mask, single-use
Earloop surgical mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 3
Strong Medical Partners LLC
5311
In Commercial Distribution

  • 10850005354359 ()
  • 00850005354352 ()
5311

  • Surgical/medical face mask, non-antimicrobial, single-use
Fluid Resistant Masks with Face Shields
ROBERT BUSSE & CO., INC.
373
In Commercial Distribution

  • 00849233000957 ()
  • 10849233000954 ()
  • 20849233000951 ()
373

  • Surgical/medical face mask, single-use
Procedural Masks
ROBERT BUSSE & CO., INC.
371
In Commercial Distribution

  • 20849233000937 ()
  • 10849233000930 ()
  • 00849233000933 ()
371

  • Surgical/medical face mask, single-use
Isolation Masks
ROBERT BUSSE & CO., INC.
370
In Commercial Distribution

  • 00849233000926 ()
  • 10849233000923 ()
  • 20849233000920 ()
370

  • Surgical/medical face mask, single-use
Procedural Facemasks Box of 50
TIDI PRODUCTS, LLC
9030
Not in Commercial Distribution

  • 10618125128430 ()
  • 00618125128433 ()
  • 01618125128432 ()
9031

  • Medical equipment/instrument drape, single-use
No Description
Dynarex Corporation
2208
In Commercial Distribution

  • 00616784220833 ()
  • 00616784220826 ()
  • 00616784220819 ()


  • Surgical/medical face mask, reprocessed
No Description
Dynarex Corporation
2206
In Commercial Distribution

  • 00616784220628 ()
  • 00616784220611 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2205
In Commercial Distribution

  • 00616784220536 ()
  • 00616784220529 ()
  • 00616784220512 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2204
In Commercial Distribution

  • 00616784220437 ()
  • 00616784220420 ()
  • 00616784220413 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2203
In Commercial Distribution

  • 00616784220338 ()
  • 00616784220321 ()
  • 00616784220314 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2202
In Commercial Distribution

  • 00616784220239 ()
  • 00616784220222 ()
  • 00616784220215 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2201
In Commercial Distribution

  • 00616784220130 ()
  • 00616784220123 ()
  • 00616784220116 ()


  • Surgical/medical face mask, reprocessed
Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.
SKYPRO ENTERPRISE LIMITED
SP01
In Commercial Distribution

  • 04897030537042 ()
  • 04897030530968 ()
FP3FNWH

  • Surgical/medical face mask, single-use
Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.
SKYPRO ENTERPRISE LIMITED
SP01
In Commercial Distribution

  • 04897030530982 ()
  • 04897030530975 ()
  • 04897030530999 ()
FP3FNWH

  • Surgical/medical face mask, single-use
Procedure Mask
KENPAX INTERNATIONAL LIMITED
1
In Commercial Distribution

  • 04895237100137 ()
  • 04895237100236 ()
68-8600-B

  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask - Flat Pleated, Ear Loops, ASTM Level 3, Lavender. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1306
In Commercial Distribution

  • 14897112130069 ()
  • 04897112130062 ()
  • 24897112130066 ()
  • 84897112130068 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask - Flat Pleated, Ear Loops, ASTM Level 3, Yellow. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1305
In Commercial Distribution

  • 14897112130052 ()
  • 04897112130055 ()
  • 24897112130059 ()
  • 84897112130051 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, White. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1304
In Commercial Distribution

  • 14897112130045 ()
  • 04897112130048 ()
  • 24897112130042 ()
  • 84897112130044 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Green. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1303
In Commercial Distribution

  • 14897112130038 ()
  • 04897112130031 ()
  • 24897112130035 ()
  • 84897112130037 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Pink. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1302
In Commercial Distribution

  • 14897112130021 ()
  • 04897112130024 ()
  • 24897112130028 ()
  • 84897112130020 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Blue. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1301
In Commercial Distribution

  • 04897112130017 ()
  • 14897112130014 ()
  • 24897112130011 ()
  • 84897112130013 ()


  • Surgical/medical face mask, single-use
Procedural Facemask Box of 50
TIDI PRODUCTS, LLC
9030A
Not in Commercial Distribution

  • 10618125189974 ()
  • 00618125189977 ()
9030A

  • Eye splash shield, single-use
Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
MS022P
In Commercial Distribution

  • 14719882250351 ()
  • 04719882250354 ()
  • 04719882250347 ()


  • Surgical/medical face mask, antimicrobial, single-use
Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
MS022G
In Commercial Distribution

  • 14719882250313 ()
  • 04719882250316 ()
  • 04719882250309 ()


  • Surgical/medical face mask, antimicrobial, single-use
Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc.
Copious International Inc.
MS042BL
In Commercial Distribution

  • 14719882253147 ()
  • 04719882253140 ()
  • 04719882253133 ()


  • Surgical/medical face mask, antimicrobial, single-use
Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc.
Copious International Inc.
MS042P
In Commercial Distribution

  • 14719882253123 ()
  • 04719882253126 ()
  • 04719882253119 ()


  • Surgical/medical face mask, antimicrobial, single-use
Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc.
Copious International Inc.
MS042G
In Commercial Distribution

  • 14719882253109 ()
  • 04719882253102 ()
  • 04719882253096 ()


  • Surgical/medical face mask, antimicrobial, single-use
Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc.
Copious International Inc.
MS042B
In Commercial Distribution

  • 14719882253086 ()
  • 04719882253089 ()
  • 04719882253072 ()


  • Surgical/medical face mask, antimicrobial, single-use
Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc.
Copious International Inc.
MS042W
In Commercial Distribution

  • 14719882253062 ()
  • 04719882253065 ()
  • 04719882253058 ()


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