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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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
Disposable 3-ply earloop procedure mask
AIME USA LLC
GFM12
In Commercial Distribution

  • 00850025200011 ()
  • 00850025200004 ()


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

  • 10850021617001 ()
  • 00850021617004 ()


  • 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
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
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