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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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
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
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
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
FE2311
Not in Commercial Distribution

  • 00850022724190 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
FE2311
Not in Commercial Distribution

  • 00850022724183 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level 3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
BYD Precision Manufacture Co., Ltd.
FE2311
In Commercial Distribution

  • 00850022724176 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level 3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
BYD Precision Manufacture Co., Ltd.
FE2311
In Commercial Distribution

  • 00850022724169 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating
Armbrust Inc.
850022550218
In Commercial Distribution

  • 00850022550218 ()
  • 00850022550256 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3
Armbrust Inc.
850022550003
In Commercial Distribution

  • 00850022550003 ()
  • 00850022550010 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
PrimaPro GentleWare ASTM Level 3 Face Mask, Blue, 4 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
B183028EL
In Commercial Distribution

  • 10850022371506 ()
  • 00850022371509 ()
  • 20850022371503 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
B182028EL
In Commercial Distribution

  • 10850022371490 ()
  • 00850022371493 ()
  • 20850022371497 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Bag, 20 Bags/Case, 1,000 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
W182028EL-BG
In Commercial Distribution

  • 10850022371483 ()
  • 00850022371486 ()
  • 20850022371480 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
W182028EL-BX
In Commercial Distribution

  • 10850022371476 ()
  • 00850022371479 ()
  • 20850022371473 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
3 Layer Surgical Mask, Level 2, White
String King Lacrosse LLC
20267
In Commercial Distribution

  • 30195376202675 ()
  • 00195376202674 ()
  • 00195376202698 ()
DMM.L2.A.WHT.1

  • Surgical/medical face mask, single-use
3 Layer Surgical Mask, Level 2, Blue
String King Lacrosse LLC
20266
In Commercial Distribution

  • 30195376202668 ()
  • 00195376202667 ()
  • 00195376202681 ()
DMM-L2-A-BLU

  • Surgical/medical face mask, non-antimicrobial, single-use
3 Layer Surgical Mask, Level 3, White
String King Lacrosse LLC
20222
In Commercial Distribution

  • 30195376202224 ()
  • 00195376202223 ()
  • 00195376202209 ()


  • Surgical/medical face mask, single-use
3 Layer Surgical Mask, Level 3, Blue
String King Lacrosse LLC
20221
In Commercial Distribution

  • 30195376202217 ()
  • 00195376202216 ()
  • 00195376202230 ()
DMM-L3-A-BLU

  • Surgical/medical face mask, non-antimicrobial, single-use
Trufit Blue Facemask (50/bx)
YOUNG INNOVATIONS HOLDINGS LLC
100114
In Commercial Distribution

  • 00843471100097 ()
100114

  • Surgical/medical face mask, single-use
No Description
UNICO GLOBAL INC
SM-301FST
In Commercial Distribution

  • 08809783490518 ()
  • 08809783490617 ()


  • Surgical/medical respirator, antimicrobial
No Description
UNICO GLOBAL INC
SM-301FS
In Commercial Distribution

  • 08809783490501 ()
  • 08809783490600 ()


  • Surgical/medical respirator, antimicrobial
No Description
UNICO GLOBAL INC
SM-301T
In Commercial Distribution

  • 08809783490099 ()
  • 08809783490594 ()


  • Surgical/medical respirator, antimicrobial
No Description
UNICO GLOBAL INC
SM-301E
In Commercial Distribution

  • 08809783490082 ()
  • 08809783490587 ()


  • Surgical/medical respirator, antimicrobial
Quala Mask Surgical Molded Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCPKA
In Commercial Distribution

  • D023GCPKA5 ()
  • D023GCPKA3 ()
  • D023GCPKA1 ()
GCPKA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIPKA
In Commercial Distribution

  • D023GCIPKA5 ()
  • D023GCIPKA3 ()
  • D023GCIPKA1 ()
GCIPKA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Lavender
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCILVA
In Commercial Distribution

  • D023GCILVA50 ()
  • D023GCILVA3 ()
  • D023GCILVA1 ()
GCILVA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIBLA
In Commercial Distribution

  • D023GCIBLA5 ()
  • D023GCIBLA3 ()
  • D023GCIBLA1 ()
GCIBLA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Surgical Molded Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCBLA
In Commercial Distribution

  • D023GCBLA55 ()
  • D023GCBLA33 ()
  • D023GCBLA13 ()
GCBLA

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-loop Mask: HOPE - Blue (Level 1)
Proguard Health, Inc
PG-MHL1
In Commercial Distribution

  • D066PGMHL11 ()
  • D066PGMHL10 ()
  • D066PGMHL12 ()
PG-MHL1

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-Loop Mask Blue (Level 3)
Proguard Health, Inc
PG-MBL3
In Commercial Distribution

  • D066PGMBL32 ()
  • D066PGMBL31 ()
  • D066PGMBL30 ()
PG-MBL3

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-Loop Mask Blue (Level 2)
Proguard Health, Inc
PG-MBL2
In Commercial Distribution

  • D066PGMBL22 ()
  • D066PGMBL21 ()
  • D066PGMBL20 ()
PG-MBL2

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-Loop Mask Blue (Level 1)
Proguard Health, Inc
PG-MBL1
In Commercial Distribution

  • D066PGMBL12 ()
  • D066PGMBL11 ()
  • D066PGMBL10 ()
PG-MBL1

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-Loop Mask Black (Level 3)
Proguard Health, Inc
PG-MBK3
In Commercial Distribution

  • D066PGMBK32 ()
  • D066PGMBK31 ()
  • D066PGMBK30 ()
PG-MBK3

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-Loop Mask Black (Level 2)
Proguard Health, Inc
PG-MBK2
In Commercial Distribution

  • D066PGMBK22 ()
  • D066PGMBK21 ()
  • D066PGMBK20 ()
PG-MBK2

  • Surgical/medical respirator, non-antimicrobial, single-use
Ear-Loop Mask Black (Level 1)
Proguard Health, Inc
PG-MBK1
In Commercial Distribution

  • D066PGMBK12 ()
  • D066PGMBK11 ()
  • D066PGMBK10 ()
PG-MBK1

  • Surgical/medical respirator, non-antimicrobial, single-use
Com-Fit Plush™ Natural Fit Masks ASTM #3 Box of 40
Sultan Healthcare Inc
20357
In Commercial Distribution

  • D687203572 ()
  • D687203571 ()
  • D687203570 ()


  • Surgical/medical face mask, single-use
Com-Fit Plush™ Natural Fit Masks ASTM #2 Box of 40
Sultan Healthcare Inc
20356
In Commercial Distribution

  • D687203562 ()
  • D687203561 ()
  • D687203560 ()


  • Surgical/medical face mask, single-use
Com-Fit Plush™ Natural Fit Masks ASTM #1 Box of 40
Sultan Healthcare Inc
20355
In Commercial Distribution

  • D687203552 ()
  • D687203551 ()
  • D687203550 ()


  • Surgical/medical face mask, single-use
com-fit Plush™ Masks CFP-3 Earloop Box of 40
Sultan Healthcare Inc
20354
In Commercial Distribution

  • D687203542 ()
  • D687203541 ()
  • D687203540 ()


  • Surgical/medical face mask, single-use
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