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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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 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
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
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
High Fluid Resistant Surgical Face Masks
United Sewing Automation, Inc.
U-325W
In Commercial Distribution

  • 00850018322003 ()
  • 00850018322126 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.
U.S. HEALTH EXPRESS CORP.
2082Blue
In Commercial Distribution

  • 00850017230026 ()
  • 00850017230002 ()
2082

  • Surgical/medical face mask, single-use
ASTM Level 3 Surgical Soft Mask, Surgical Ties, White
Revo Medical Products Inc
RM1793
In Commercial Distribution

  • 00850035252277 ()
  • 00850035252215 ()
  • 00850035252055 ()


  • Surgical/medical face mask, single-use
ASTM Level 3 Surgical Anti-Fog Tape Mask, Surgical Ties, Green
Revo Medical Products Inc
RM1798
In Commercial Distribution

  • 00850035252321 ()
  • 00850035252208 ()
  • 00850035252109 ()


  • Surgical/medical face mask, single-use
ASTM Level 1 Procedure Mask, Earloop, Yellow
Revo Medical Products Inc
RM1797
In Commercial Distribution

  • 00850035252314 ()
  • 00850035252192 ()
  • 00850035252093 ()


  • Surgical/medical face mask, single-use
ASTM Level 3 Procedure Soft Mask, Earloop, White
Revo Medical Products Inc
RM1794
In Commercial Distribution

  • 00850035252284 ()
  • 00850035252161 ()
  • 00850035252062 ()


  • Surgical/medical face mask, single-use
ASTM Level 3 Surgical Duckbill Mask, Surgical Ties, Green
Revo Medical Products Inc
RM1792
In Commercial Distribution

  • 00850035252260 ()
  • 00850035252154 ()
  • 00850035252048 ()


  • Surgical/medical face mask, single-use
ASTM Level 3 Surgical Anti-Fog Foam Mask, Surgical Ties, Iris
Revo Medical Products Inc
RM1791
In Commercial Distribution

  • 00850035252253 ()
  • 00850035252147 ()
  • 00850035252031 ()


  • Surgical/medical face mask, single-use
ASTM Level 3 Surgical Anti-Fog Film Mask, Surgical Ties, Green
Revo Medical Products Inc
RM1790
In Commercial Distribution

  • 00850035252024 ()
  • 00850035252130 ()
  • 00850035252246 ()


  • Surgical/medical face mask, single-use
ASTM Level 1 Procedure Mask, Earloop, Blue
Revo Medical Products Inc
RM1789
In Commercial Distribution

  • 00850035252239 ()
  • 00850035252123 ()
  • 00850035252017 ()


  • Surgical/medical face mask, single-use
ASTM Level 3 Procedure Anti-Fog Foam Mask, Earloop, Iris
Revo Medical Products Inc
RM1788
In Commercial Distribution

  • 00850035252000 ()
  • 00850035252116 ()
  • 00850035252222 ()


  • Surgical/medical face mask, single-use
1MED Surgical Mask, Level 1, Earloop style non-sterile, single-use, 50ct Box
Qyk Brands LLC
1MED-13LSM1
In Commercial Distribution

  • 00850039859496 ()
  • 00850039859502 ()
  • 10850039859509 ()


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