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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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Advance Plus™ Earloop Procedure Masks - 10810012650028

Earloop Procedure Masks, ASTM Level 3, Pink, Box
SOUTHERN ANESTHESIA & SURGICAL, INC.
ADV2315
In Commercial Distribution

  • 20810012650025 ()
  • 10810012650028 ()
  • 00810012650021 ()
ADV2315

  • Surgical/medical face mask, single-use

Advance Plus™ Earloop Procedure Masks - 10810012650004

Earloop Procedure Masks, ASTM Level 1, Pink, Box
SOUTHERN ANESTHESIA & SURGICAL, INC.
ADV2308
In Commercial Distribution

  • 20810012650001 ()
  • 10810012650004 ()
  • 00810012650007 ()
ADV2308

  • Surgical/medical face mask, single-use

Ear-Friendly Mask - 08800003025008

No Description
Ray Co., Ltd
Ear-Friendly Mask
In Commercial Distribution

  • 08800003025008 ()
  • 08800003025206 ()


  • Surgical/medical face mask, single-use

ASP MEDICAL - 10840216107967

MASK, SURGICAL, BLUE, EARLOOP 3-PLY, LEVEL 2, 50EA/BX, 40BX/CS (2000EA/CS)
Asp Global, LLC
FMT605
In Commercial Distribution

  • 00840216107960 ()
  • 10840216107967 ()
  • 20840216107964 ()
FMT605

  • Surgical/medical face mask, single-use

Tiger Medical Products - 10840216101422

Surgical Face Mask, 3 Ply, Earloops
Tiger Medical Group
FMT517
In Commercial Distribution

  • 20840216101429 ()
  • 10840216101422 ()
  • 00840216101425 ()


  • Surgical/medical face mask, single-use

Tiger Medical Products - 10840216101415

Surgical Face Mask, Tie-On, Blue
Tiger Medical Group
FMT510
In Commercial Distribution

  • 20840216101412 ()
  • 10840216101415 ()
  • 00840216101418 ()


  • Surgical/medical face mask, single-use

Tiger Medical Products - 10840216101408

Surgical Face mask, Tie-On White
Tiger Medical Group
FMT508
In Commercial Distribution

  • 20840216101405 ()
  • 10840216101408 ()
  • 00840216101401 ()


  • Surgical/medical face mask, single-use

Tiger Medical Products - 10840216101392

Mask Surgical, Tie-On, Anti-Fog
Tiger Medical Group
FMT505
In Commercial Distribution

  • 20840216101399 ()
  • 10840216101392 ()
  • 00840216101395 ()


  • Surgical/medical face mask, single-use

Tiger Medical Products - 10840216101385

Isolation Mask Earloops Yellow
Tiger Medical Group
FMT504
In Commercial Distribution

  • 10840216101385 ()
  • 00840216101388 ()
  • 20840216101382 ()


  • Surgical/medical face mask, single-use

Face Mask - 10851253007912

No Description
ULINE, INC.
S-10478-S1
In Commercial Distribution

  • 30851253007916 ()
  • 10851253007912 ()
  • 00851253007915 ()


  • Surgical/medical face mask, single-use

Uline - 10851253007561

Deluxe Surgical Mask
ULINE, INC.
S-22137
In Commercial Distribution

  • 30851253007565 ()
  • 10851253007561 ()
  • 00851253007564 ()
S-22137

  • Surgical/medical face mask, single-use

ULINE Surgical Mask with Eye Shield - 10851253007424

Light blue polypropylene surgical Mask with ear loops and eye shield with adjustable aluminum nose piece.
ULINE, INC.
S-21078
In Commercial Distribution

  • 10851253007424 ()
  • 00851253007427 ()
  • 30851253007428 ()
S-21078

  • Surgical/medical face mask, single-use

ULINE Tie-Back Surgical Mask - 10851253007417

Light blue polypropylene tie-back surgical mask with adjustable aluminum nose piece.
ULINE, INC.
S-19254
In Commercial Distribution

  • 30851253007411 ()
  • 10851253007417 ()
  • 00851253007410 ()
S-19254

  • Surgical/medical face mask, single-use

HYGITECH - 03615140000406

Total protection of the face, eyes and forehead Elastic 3 ply mask with nose clip, EN 14683 Fully transparent panoramic visor No glass fibres, latex-free, odourless . Comfortable: flexible nose piece sheathed steel 9cm High strength visor stitched to the mask Anti-fog treatment on the inside and front of the shield Doesn't affect vision during procedure Perfect protection: 30cm wrap-around visor Lightweight: 11g Can be worn with precription glasses Packed individually keeping the visors in perfect condition
HYGITECH
HY-07011
In Commercial Distribution

  • 03615140000413 ()
  • 03615140000406 ()
HY-07011

  • Face splash shield, single-use

HYGITECH - 03615140000192

The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures. Characteristics : • A Velcro strap allows comfortable adjustment of the loupe around the head • The loupe can be moved up and down to better align the eyes with the magnified area • The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object • Available in two magnifications, x2.5 or x3.5 Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use. Light - Weighing only 70g, the HYGITECH loupe is remarkably light. Practical - Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field
HYGITECH
HY-07106
In Commercial Distribution

  • 03615140000208 ()
  • 03615140000192 ()
HY-07106

  • Lens loop, reusable

HYGITECH - 03615140000178

The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures. Characteristics : • A Velcro strap allows comfortable adjustment of the loupe around the head • The loupe can be moved up and down to better align the eyes with the magnified area • The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object • Available in two magnifications, x2.5 or x3.5 Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use. Light - Weighing only 70g, the HYGITECH loupe is remarkably light. Practical - Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field
HYGITECH
HY-07104
In Commercial Distribution

  • 03615140000185 ()
  • 03615140000178 ()
HY-07104

  • Lens loop, reusable

HYGITECH - 03615140000161

Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination Frame available in 3 colours: white, blue, pink Light: 22 grams Comfortable frame, it adapts to all face types Handy: Shields easy to fit Perfect protection: 30cm shield protects the whole face The shield assures clear vision, Abrasion and scratch-resistant
HYGITECH
HY-07003
In Commercial Distribution

  • 03615140003957 ()
  • 03615140000161 ()
HY-07003

  • Face splash shield, single-use

HYGITECH - 03615140000154

Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination Frame available in 3 colours: white, blue, pink Light: 22 grams Comfortable frame, it adapts to all face types Handy: Shields easy to fit Perfect protection: 30cm shield protects the whole face The shield assures clear vision, Abrasion and scratch-resistant
HYGITECH
HY-07002
In Commercial Distribution

  • 03615140003940 ()
  • 03615140000154 ()
HY-07002

  • Face splash shield, single-use

HYGITECH - 03615140000147

Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination Frame available in 3 colours: white, blue, pink Light: 22 grams Comfortable frame, it adapts to all face types Handy: Shields easy to fit Perfect protection: 30cm shield protects the whole face The shield assures clear vision, Abrasion and scratch-resistant
HYGITECH
HY-07001
In Commercial Distribution

  • 03615140003933 ()
  • 03615140000147 ()
HY-07001

  • Face splash shield, single-use

HYGITECH - 03615140000123

Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination Frame available in 3 colours: white, blue, pink Light: 22 grams Comfortable frame, it adapts to all face types Handy: Shields easy to fit Perfect protection: 30cm shield protects the whole face The shield assures clear vision, Abrasion and scratch-resistant
HYGITECH
HY-07009
In Commercial Distribution

  • 03615140000130 ()
  • 03615140000123 ()
HY-07009

  • Face splash shield, single-use

Indiana Face Mask - B959IFMSM30

ASTM Level 3 Surgical Mask
Fssc LLC
IFM-SM3
In Commercial Distribution

  • B959IFMSM31 ()
  • B959IFMSM30 ()
  • B959IFMSM300 ()


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

EXCEL Procedure Mask 3 ply level 1, 50 per box, mint green - B958FM388G1

PROCEDURE MASK 3 PLY LEVEL 1 MINT GREEN, 50 PER BOX
Excel Gloves & Safety Supplies, Inc.
FM 388G Mint Green
In Commercial Distribution

  • B958FM388G1 ()
  • B958FM388 ()
0503FM388G

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

Procedure Mask 3 ply level 1, color 50 per box, BLACK - B958FM388BLK1

Procedure Mask 3 ply level 1, color 50 per box color black
Excel Gloves & Safety Supplies, Inc.
FM BLACK
In Commercial Distribution

  • B958FM3881 ()
  • B958FM388BLK1 ()
  • B958FM388BLK1 ()


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

BASIC - B845FM301A50W1

No Description
Intco Medical Industries, Inc.
FM301A50W
In Commercial Distribution

  • B845FM301A50W3 ()
  • B845FM301A50W1 ()
  • B845FM301A50W0 ()


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

BASIC - B845FM301A50K1

No Description
Intco Medical Industries, Inc.
FM301A50K
In Commercial Distribution

  • B845FM301A50K3 ()
  • B845FM301A50K1 ()
  • B845FM301A50K0 ()


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

BASIC - B845FM301A501

No Description
Intco Medical Industries, Inc.
FM301A50
In Commercial Distribution

  • B845FM301A503 ()
  • B845FM301A501 ()
  • B845FM301A50 ()


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

Zhou Medical N95 Respirator Mask - S - B820Z1201020

Zhou Medical N95 NIOSH Respirator Mask - Small
ZHOU MEDICAL SOLUTIONS LLC
1
In Commercial Distribution

  • B820Z1201020 ()
  • B820Z1201021 ()
Z120102

  • Surgical/medical respirator, non-antimicrobial, single-use

Zhou Medical N95 Respirator Mask - B820Z1201010

Zhou Medical N95 NIOSH Respirator Mask
ZHOU MEDICAL SOLUTIONS LLC
1
In Commercial Distribution

  • B820Z1201010 ()
  • B820Z1201011 ()
Z120101

  • Surgical/medical respirator, non-antimicrobial, single-use

Paneffort - 10810101310550

ASTM Level 2 3-Ply Procedure Mask with Earloops. Blue.
Paneffort, LLC
42146
In Commercial Distribution

  • 20810101310557 ()
  • 10810101310550 ()
  • 00810101310553 ()


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

VIVIT - 10810084210175

Medical Face Mask - Ties, Anti-Fog Visor, Anti-Fog Foam, Opal, 160mm Hg ASTM Level 3
1. Vivit International Inc
313241TMV
In Commercial Distribution

  • 20810084210172 ()
  • 10810084210175 ()
  • 00810084210178 ()


  • Surgical/medical face mask, single-use

VIVIT - 10810084210151

Medical Face Mask - Ties, Opal, 160mm Hg ASTM Level 3
1. Vivit International Inc
30314TM
In Commercial Distribution

  • 20810084210158 ()
  • 10810084210151 ()
  • 00810084210154 ()


  • Surgical/medical face mask, single-use

VIVIT - 10810084210137

Medical Face Mask - Ties, Anti-Fog Film, Green, 80mm Hg ASTM Level 1
1. Vivit International Inc
12313TM
In Commercial Distribution

  • 20810084210134 ()
  • 10810084210137 ()
  • 00810084210130 ()


  • Surgical/medical face mask, single-use

Hopkins Medical Products® - 10817643020534

Procedure Mask With Eyeshield 25/PK
HOPKINS UNIFORM COMPANY
695198
In Commercial Distribution

  • 10817643020534 ()
  • 00817643020537 ()
695198

  • Surgical/medical face mask, single-use

Hopkins Medical Products® - 10817643020145

Procedure Mask PK50
HOPKINS UNIFORM COMPANY
19696
In Commercial Distribution

  • 10817643020145 ()
19696

  • Surgical/medical face mask, single-use

Critical Cover - 10817583020618

EARLOOP, WHITE
Alpha Pro Tech, Inc.
WH6155BEN
In Commercial Distribution

  • 20817583020615 ()
  • 10817583020618 ()
  • 00817583020611 ()
WH6155BEN

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

Critical Cover - 10817583020595

EARLOOP, BLUE
Alpha Pro Tech, Inc.
BL6155BEN
In Commercial Distribution

  • 20817583020592 ()
  • 10817583020595 ()
  • 00817583020598 ()
BL6155BEN

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

Critical Cover - 10817583020571

TIE STRING MASK, BLUE
Alpha Pro Tech, Inc.
BL6001CC
Not in Commercial Distribution

  • 10817583020571 ()
  • 00817583020574 ()
  • 20817583020578 ()
BL6001CC

  • Surgical hood

Critical Cover - 10817583020564

TIE STRING MASK, BLUE
Alpha Pro Tech, Inc.
BL5500
In Commercial Distribution

  • 20817583020561 ()
  • 10817583020564 ()
  • 00817583020567 ()
BL5500

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

SHIELDMATE - 10817583020557

EARLOOP MASK W/EXTENDED SHIELD, BLUE 5 MIL.
Alpha Pro Tech, Inc.
SHI SM 2005X
In Commercial Distribution

  • 20817583020554 ()
  • 10817583020557 ()
  • 00817583020550 ()
SHI SM 2005X

  • Eye splash shield, single-use

COMBO - 10817583020502

EARLOOP MASKW/SHIELD AND SNAPS, BLUE 7 MIL.
Alpha Pro Tech, Inc.
SHI5194E
In Commercial Distribution

  • 20817583020509 ()
  • 10817583020502 ()
  • 00817583020505 ()
SHI5194E

  • Eye splash shield, single-use
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