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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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
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
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
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
Plant Based Procedural Mask ASTM Level 3 with ear loops
Safesource Direct, L.L.C.
PM3003-W-ECO
In Commercial Distribution

  • 00850037747382 ()
  • 00850060904080 ()
  • 10850037747389 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Blue ASTM Level 3 Procedure Mask with soft ear loops
Safesource Direct, L.L.C.
PM3003
In Commercial Distribution

  • 00850037747153 ()
  • 00850037747597 ()
  • 00850037747399 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Blue ASTM Level 1 Procedure Mask with soft ear loops
Safesource Direct, L.L.C.
PM3001
In Commercial Distribution

  • 00850037747146 ()
  • 00850037747580 ()
  • 10850037747143 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Blue ASTM Level 3 Surgical Mask with Ties
Safesource Direct, L.L.C.
SM3003
In Commercial Distribution

  • 00850037747139 ()
  • 00850037747610 ()
  • 10850037747136 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Blue ASTM 1 Surgical Mask with Ties
Safesource Direct, L.L.C.
SM3001
In Commercial Distribution

  • 00850037747122 ()
  • 20850037747126 ()
  • 10850037747129 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 1 Tie Mask, Soft, White
Resilient Medical Solutions, LLC
RMTM1S
In Commercial Distribution

  • 10850037100146 ()
  • 00850037100149 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 3 Tie Mask with Anti-Fog Foam and Anti-Glare/Anti-Fog Visor, Violet
Resilient Medical Solutions, LLC
RMTM3FV
In Commercial Distribution

  • 10850037100139 ()
  • 00850037100132 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 1 Tie Mask with Anti-Fog Film, Green
Resilient Medical Solutions, LLC
RMTM1F
In Commercial Distribution

  • 00850037100125 ()
  • 10850037100122 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 1 Tie Mask with Anti-Fog Adhesive, Green
Resilient Medical Solutions, LLC
RMTM1T
In Commercial Distribution

  • 10850037100115 ()
  • 00850037100118 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 1 Tie Mask, White
Resilient Medical Solutions, LLC
RMTM1
In Commercial Distribution

  • 10850037100108 ()
  • 00850037100101 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Pediatric Face Cover, Blue
Resilient Medical Solutions, LLC
RMEMPFC
In Commercial Distribution

  • 10850037100092 ()
  • 00850037100095 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 3 Ear loop Mask with Anti-Fog Foam and Anti-Fog Visor, Violet
Resilient Medical Solutions, LLC
RMEM3FV
In Commercial Distribution

  • 10850037100085 ()
  • 00850037100088 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level Earloop Mask with Anti-Fog Foam, Violet
Resilient Medical Solutions, LLC
RMEM3F
In Commercial Distribution

  • 10850037100078 ()
  • 00850037100071 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 3 Earloop Mask, Violet 50 pcs box
Resilient Medical Solutions, LLC
RMEM3
In Commercial Distribution

  • 10850037100061 ()
  • 00850037100064 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
ASTM Level 1 Ear loop Mask, Blue 50 pcs, bx
Resilient Medical Solutions, LLC
RMEM1
In Commercial Distribution

  • 10850037100054 ()
  • 00850037100057 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3PLY Procedure Mask; surgical mask
Texas Medical Technology Inc
3PLY-PRCMSK-04
In Commercial Distribution

  • 00850032920568 ()
3PLY-PRCMSK-04

  • Surgical/medical face mask, non-antimicrobial, 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
1MED Surgical Mask, Level 3, Earloop style non-sterile, single-use, 50ct Box
Qyk Brands LLC
1MED-33LSM1
In Commercial Distribution

  • 00850039859472 ()
  • 00850027748658 ()
  • 10850039859479 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
1MED Surgical Mask, Level 2, Earloop style non-sterile, single-use, 50ct Box
Qyk Brands LLC
1MED-23LSM1
In Commercial Distribution

  • 00850039859489 ()
  • 00850039859465 ()
  • 10850039859462 ()


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

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


  • 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 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
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