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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Level 3 Procedure Face Mask with Ear Loops - 3 Layers
Blackbriar Regulatory Services, LLC
850021617561
In Commercial Distribution

  • 00850021617578 ()
  • 00850021617561 ()
BRS3561

  • Surgical/medical face mask, single-use
Level 2 Procedure Face Mask with Ear Loops
Blackbriar Regulatory Services, LLC
850021617196
In Commercial Distribution

  • 10850021617193 ()
  • 00850021617196 ()
BRS2189

  • Surgical/medical face mask, single-use
Level 1 Procedure Face Mask with Ear Loops - Updated
Blackbriar Regulatory Services, LLC
850021617004
In Commercial Distribution

  • 10850021617001 ()
  • 00850021617004 ()


  • Surgical/medical face mask, single-use
The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear bands to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex
Texas Medplast, LLC
SM03
In Commercial Distribution

  • 10850025566169 ()
  • 00850025566162 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear loops to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex
Texas Medplast, LLC
SM01
In Commercial Distribution

  • 10850025566138 ()
  • 00850025566131 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable 3-ply earloop procedure mask
AIME USA LLC
GFM12
In Commercial Distribution

  • 00850025200011 ()
  • 00850025200004 ()


  • Surgical/medical face mask, single-use
Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.
Premier Guard Usa, LLC
20-1001-FM
In Commercial Distribution

  • 00850019294026 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex.
Premier Guard Usa, LLC
20-1002-SFM3
In Commercial Distribution

  • 00850019294156 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs
Premier Guard Usa, LLC
20-1002-SFM3
In Commercial Distribution

  • 00850019294019 ()
  • 00850019294330 ()
  • 10850019294016 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs
Premier Guard Usa, LLC
20-1003-SFM2
In Commercial Distribution

  • 00850019294002 ()
  • 00850019294347 ()
  • 20850019294006 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 4-Ply Surgical Mask (Model:62232) Outer Case of 2,000 Masks
Altor Safety LLC
62232
In Commercial Distribution

62232

  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

62232

  • Surgical/medical face mask, non-antimicrobial, single-use
No Description
MOCACARE CORP.
Surgical Mask
In Commercial Distribution

  • 00850842006308 ()


  • Public face mask, single-use
No Description
MOCACARE CORP.
Procedure Mask
In Commercial Distribution

  • 00850842006292 ()


  • Public face mask, single-use
ASTM Level 2 Face Masks Ear Loop, BFE 99%, Extra enlarged 3 Fold Blue 50 pcs box
Complete Dental Supplies LLC
20089-CDS
In Commercial Distribution

  • 00850055627246 ()
  • 00850055627055 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable Face Mask Level 1
Neil Medical Group
FM1010
In Commercial Distribution

  • 00850063139250 ()
  • 00850063139267 ()
  • 85006313926700 ()
FM1010

  • Surgical/medical face mask, non-antimicrobial, reusable
Surgical Mask LV2
Calico Medical Group LLC
SM002
In Commercial Distribution

  • 20850044458916 ()
  • 00850044458912 ()
  • 10850044458919 ()
SM002

  • Surgical/medical face mask, non-antimicrobial, single-use
Surgical Mask LV1
Calico Medical Group LLC
SM001
In Commercial Distribution

  • 20850044458909 ()
  • 00850044458905 ()
  • 10850044458902 ()
SM001

  • Surgical/medical face mask, non-antimicrobial, single-use
American Hospital Supply (AHS) Earloop Masks Disposable | Case of 2000 (40 Boxes)
American Hospital Supply LLC
AHSFM1_CS
In Commercial Distribution

  • 00850046814471 ()
  • 00850037921188 ()
AHSFM1_CS

  • Surgical/medical face mask, non-antimicrobial, single-use
American Hospital Supply (AHS) Earloop Masks Disposable | Box of 50
American Hospital Supply LLC
AHSFM1_BX
In Commercial Distribution

  • 00850037921164 ()
  • 00850037921171 ()
AHSFM1_BX

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