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, TUTEM-GENTLE MANNERS
Alpha Pro Tech, Inc.
6055-7 GENTLE MANNERS
Not in Commercial Distribution

  • 10817583020410 ()
  • 00817583020413 ()
6055-7 GENTLE MANNERS

  • Surgical hood
EARLOOP, TUTEM- KEEP IT TO YOURSELF.
Alpha Pro Tech, Inc.
6055-6 KEEP IT TO YOURSELF
Not in Commercial Distribution

  • 10817583020403 ()
  • 00817583020406 ()
6055-6 KEEP IT TO YOURSELF

  • Surgical hood
EARLOOP, TUTEM-COLD COUTURE.
Alpha Pro Tech, Inc.
6055-5 COLD COUTURE
Not in Commercial Distribution

  • 10817583020397 ()
  • 00817583020390 ()
6055-5 COLD COUTURE

  • Surgical hood
EARLOOP, TUTEM-MICROBE MANAGER
Alpha Pro Tech, Inc.
6055-4 MICROBE MANAGER
Not in Commercial Distribution

  • 10817583020380 ()
  • 00817583020383 ()
6055-4 MICROBE MANAGER

  • Surgical hood
EARLOOP, TUTEM-DON'T GO VIRAL
Alpha Pro Tech, Inc.
6055-3 DON'T GO VIRAL
Not in Commercial Distribution

  • 10817583020373 ()
  • 00817583020376 ()
6055-3 DON'T GO VIRAL

  • Surgical hood
EARLOOP, TUTEM-BUSINESS CLASS
Alpha Pro Tech, Inc.
6055-2 Business Class
Not in Commercial Distribution

  • 10817583020366 ()
  • 00817583020369 ()
6055-2 Business Class

  • Surgical hood
EARLOOP, TUTEM -SOCIAL BUTTERFLY
Alpha Pro Tech, Inc.
6055-1 Social Butterfly
Not in Commercial Distribution

  • 10817583020359 ()
  • 00817583020352 ()
6055-1 Social Butterfly

  • Surgical hood
Level 3 4ply Face Mask Dual Bands Blue 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1975BLCASE
In Commercial Distribution

  • D7961975BLCASE3 ()
  • D7961975BLCASE2 ()
1975BLCASE

  • Surgical/medical face mask, single-use
Level 3 4ply Face Mask Dual Bands Blue 50/bx. - MARK3®
CARGUS INTERNATIONAL, INC
1975BL
In Commercial Distribution

  • D7961975BL2 ()
  • D7961975BL1 ()
1975BL

  • Surgical/medical face mask, single-use
Level 3 4ply Fog Free Face Mask Blue 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1974BLCASE
In Commercial Distribution

  • D7961974BLCASE3 ()
  • D7961974BLCASE2 ()
1974BLCASE

  • Surgical/medical face mask, single-use
Level 3 4ply Fog Free Face Mask Blue 50/bx. - MARK3®
CARGUS INTERNATIONAL, INC
1974BL
In Commercial Distribution

  • D7961974BL2 ()
  • D7961974BL1 ()
1974BL

  • Surgical/medical face mask, single-use
Level 3 4ply Face Mask White 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1973WHCASE
In Commercial Distribution

  • D7961973WHCASE3 ()
  • D7961973WHCASE2 ()
1973WHCASE

  • Surgical/medical face mask, single-use
Level 3 4ply Face Mask White 50/bx. - MARK3®
CARGUS INTERNATIONAL, INC
1973WH
In Commercial Distribution

  • D7961973WH2 ()
  • D7961973WH1 ()
1973WH

  • Surgical/medical face mask, single-use
Level 3 4ply Face Mask Pink 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1973PICASE
In Commercial Distribution

  • D7961973PICASE3 ()
  • D7961973PICASE2 ()
1973PICASE

  • Surgical/medical face mask, single-use
Level 3 4ply Face Mask Pink 50/bx. - MARK3®
CARGUS INTERNATIONAL, INC
1973PI
In Commercial Distribution

  • D7961973PI2 ()
  • D7961973PI1 ()
1973PI

  • Surgical/medical face mask, single-use
Level 3 4ply Face Mask Blue 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1973BLCASE
In Commercial Distribution

  • D7961973BLCASE3 ()
  • D7961973BLCASE2 ()
1973BLCASE

  • Surgical/medical face mask, single-use
Level 1 3ply Face Mask White 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1971WHCASE
In Commercial Distribution

  • D7961971WHCASE3 ()
  • D7961971WHCASE2 ()
1971WHCASE

  • Surgical/medical face mask, single-use
Level 1 3ply Face Mask Pink 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1971PICASE
In Commercial Distribution

  • D7961971PICASE3 ()
  • D7961971PICASE2 ()
1971PICASE

  • Surgical/medical face mask, single-use
Level 1 3ply Face Mask Lavender 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1971LACASE
In Commercial Distribution

  • D7961971LACASE3 ()
  • D7961971LACASE2 ()
1971LACASE

  • Surgical/medical face mask, single-use
Level 1 3Ply Face Mask Blue 40bx./CS - MARK3®
CARGUS INTERNATIONAL, INC
1971BLCASE
In Commercial Distribution

  • D7961971BLCASE3 ()
  • D7961971BLCASE2 ()
1971BLCASE

  • Surgical/medical face mask, single-use
TQMPL Face Mask - ASTM 2 - Blue
TOP QUALITY MANUFACTURING, INC.
FM2-1810
In Commercial Distribution

  • TQ26FM2181010 ()
  • TQ26FM2181011 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL Face Mask - ASTM 1 - White - New
TOP QUALITY MANUFACTURING, INC.
FM2-1806
In Commercial Distribution

  • TQ26FM2180610 ()
  • TQ26FM2180611 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL Face Mask - ASTM 1 - Yellow - New
TOP QUALITY MANUFACTURING, INC.
FM2-1805
In Commercial Distribution

  • TQ26FM2180510 ()
  • TQ26FM2180511 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL Face Mask - ASTM 1 - Purple / Lavender - New
TOP QUALITY MANUFACTURING, INC.
FM2-1803
In Commercial Distribution

  • TQ26FM2180310 ()
  • TQ26FM2180311 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL Face Mask - ASTM 1 - Blue - New
TOP QUALITY MANUFACTURING, INC.
FM2-1801
In Commercial Distribution

  • TQ26FM2180110 ()
  • TQ26FM2180111 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL - Face Mask - ASTM 3 - Earloop - 4-ply - Black - 50 / box
TOP QUALITY MANUFACTURING, INC.
18015110
In Commercial Distribution

  • TQ26180151100 ()
  • TQ26180151101 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL - Face Mask - ASTM 3 - Earloop - 4-ply - Pink - 50 / box
TOP QUALITY MANUFACTURING, INC.
18015109
In Commercial Distribution

  • TQ26180151090 ()
  • TQ26180151091 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL - Face Mask - ASTM 3 - Earloop - 4-ply - Blue - 50 / box
TOP QUALITY MANUFACTURING, INC.
18015108
In Commercial Distribution

  • TQ26180151080 ()
  • TQ26180151081 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL - Face Mask - ASTM 3 - Earloop - 4-ply - Purple - 50 / box
TOP QUALITY MANUFACTURING, INC.
18015107
In Commercial Distribution

  • TQ26180151070 ()
  • TQ26180151071 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
PureLife Level 3 Masks Pink
PURELIFE, LLC
1154902
In Commercial Distribution

  • D79011549023 ()
  • D79011549021 ()
  • D79011549020 ()
1154902

  • Surgical/medical face mask, single-use
PureLife Level 3 Masks Blue
PURELIFE, LLC
1154901
In Commercial Distribution

  • D79011549013 ()
  • D79011549011 ()
  • D79011549010 ()
1154901

  • Surgical/medical face mask, single-use
Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece
PURELIFE, LLC
1150102
In Commercial Distribution

  • D79011501023 ()
  • D79011501021 ()
  • D79011501020 ()
1150102

  • Surgical/medical face mask, single-use
Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece
PURELIFE, LLC
1150101
In Commercial Distribution

  • D79011501013 ()
  • D79011501011 ()
  • D79011501010 ()
1150101

  • Surgical/medical face mask, single-use
TQMPL Face Mask - ASTM 1 - Green / Turquoise - New
TOP QUALITY MANUFACTURING, INC.
FM2-1804
In Commercial Distribution

  • TQ26FM2180410 ()
  • TQ26FM2180411 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL Face Mask - ASTM 1 - Pink - New
TOP QUALITY MANUFACTURING, INC.
FM2-1802
In Commercial Distribution

  • TQ26FM2180210 ()
  • TQ26FM2180211 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable Surgical Face Mask (ASTM F2100 LEVEL3)
FORA CARE INC.
ASTM-L3
In Commercial Distribution

  • 00816042014352 ()
  • 80816042014358 ()


  • Surgical/medical face mask, single-use
Facemask, ASTM Level 2, Earloop
MYCO MEDICAL SUPPLIES INC.
MYEL 20000
In Commercial Distribution

  • 20386120010933 ()
  • 10386120010936 ()
  • 00386120010939 ()
MYEL 20000

  • Surgical/medical face mask, single-use
Facemask, ASTM Level 2, Tie-On
MYCO MEDICAL SUPPLIES INC.
MYTO 20000
In Commercial Distribution

  • 20386120010896 ()
  • 10386120010899 ()
  • 00386120010892 ()
MYTO 20000

  • Surgical/medical face mask, single-use
Facemask, ASTM Level 3, Tie-On
MYCO MEDICAL SUPPLIES INC.
MYTO 30000
In Commercial Distribution

  • 20386120010889 ()
  • 10386120010882 ()
  • 00386120010885 ()
MYTO 30000

  • Surgical/medical face mask, single-use
Facemask, ASTM Level 3, Earloop
MYCO MEDICAL SUPPLIES INC.
MYEL 30000
In Commercial Distribution

  • 20386120010865 ()
  • 10386120010868 ()
  • 00386120010861 ()
MYEL 30000

  • Surgical/medical face mask, single-use
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