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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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RAGNELL SCISSORS - 00192896075436

RAGNELL SCISSORS UNDER MINING SPATULATED CURVED BLADES POWER CUT SILVER
SONTEC INSTRUMENTS, INC.
110-318
In Commercial Distribution

  • 00192896075436 ()

  • Length: 9 Inch
110-318

  • General-purpose surgical scissors, reusable

Welch Allyn, Inc. - 00732094014464

Welch Allyn LumiView 3.5 V Halogen Portable Binocular Microscope with Headband, Portable Battery Pack (#75200), Reusable Ear Speculum Set (#22100); 120 V, 60 Hz AC, Nickel-Cadmium (#72250) Battery; IEC Plug Type-A
WELCH ALLYN, INC.
901037
In Commercial Distribution

  • 00732094014464 ()
20500H

  • Mobile examination/treatment room light

Welch Allyn, Inc. - 00732094014129

Welch Allyn LumiView 3.5 V Halogen Portable Binocular Microscope with Headband, Reusable Ear Speculum Set (#22100); 120 V, 60 Hz AC, IEC Plug Type-A
WELCH ALLYN, INC.
901037
In Commercial Distribution

  • 00732094014129 ()
20510H

  • Mobile examination/treatment room light

Welch Allyn, Inc. - 00732094014112

Welch Allyn LumiView 3.5 V Halogen Portable Binocular Microscope with Spectacle Mount, Reusable Ear Speculum Set (#22100); 120 V, 60 Hz AC, IEC Plug Type-A
WELCH ALLYN, INC.
901037
In Commercial Distribution

  • 00732094014112 ()
20510S

  • Mobile examination/treatment room light

Welch Allyn, Inc. - 00732094014440

Welch Allyn LumiView 3.5 V Halogen Portable Binocular Microscope with Spectacle Mount, Portable Battery Pack (#75200), Reusable Ear Speculum Set (#22100); 120 V, 60 Hz AC, Nickel-Cadmium (#72250) Battery; IEC Plug Type-A
WELCH ALLYN, INC.
901037
In Commercial Distribution

  • 00732094014440 ()
20500S

  • Mobile examination/treatment room light

Welch Allyn, Inc. - 00732094014013

Welch Allyn 3.5V LumiView Portable Microscope, Headband Mount Only
WELCH ALLYN, INC.
901037
In Commercial Distribution

  • 00732094014013 ()
20530H

  • Mobile examination/treatment room light

Welch Allyn, Inc. - 00732094013979

Welch Allyn 3.5 V Halogen Flat Surface Magnifier with Spectacle Mount; Spectacles Not Included
WELCH ALLYN, INC.
901037
In Commercial Distribution

  • 00732094013979 ()
20540S

  • Mobile examination/treatment room light

VorOtek O Scope - 09348227002089

VorOtek O Scope - SpecFrame - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 3 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSOS-3D
In Commercial Distribution

  • 09348227002089 ()
VSOS-3D

  • Surgical binoculars, reusable

VorOtek O Scope - 09348227001938

VorOtek O Scope - HeadBand - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 3 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSOH-3D
In Commercial Distribution

  • 09348227001938 ()
VSOH-3D

  • Surgical binoculars, reusable

VorOtek M Scope - 09348227000160

VorOtek M Scope - SpecFrame. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSMS
In Commercial Distribution

  • 09348227000160 ()
VSMS

  • Surgical binoculars, reusable

VorOtek M Scope - 09348227000153

VorOtek M Scope - HeadBand. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSMH
In Commercial Distribution

  • 09348227000153 ()
VSMH

  • Surgical binoculars, reusable

VorOtek L Scope - 09348227000139

VorOtek L Scope - SpecFrame. 2.5X Magnification Loupes @ 42cm working distance with Fully Integrated Surgical Quality Dimmable LED Illumination. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSLS-2.5 M
In Commercial Distribution

  • 09348227000139 ()
VSLS-2.5 M

  • Surgical binoculars, reusable

VorOtek L Scope - 09348227000122

VorOtek L Scope - SpecFrame. 2.5X Magnification Loupes @ 47cm working distance with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSLS-2.5 L
In Commercial Distribution

  • 09348227000122 ()
VSLS-2.5 L

  • Surgical binoculars, reusable

VorOtek L Scope - 09348227000108

VorOtek L Scope - HeadBand 2.5X Magnification Loupes @ 42cm working distance with Fully Integrated Surgical Quality Dimmable LED Illumination. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSLH-2.5 M
In Commercial Distribution

  • 09348227000108 ()
VSLH-2.5 M

  • Surgical binoculars, reusable

VorOtek L Scope - 09348227000092

VorOtek L Scope - HeadBand. 2.5X Magnification Loupes @ 47cm working distance with Fully Integrated Surgical Quality Dimmable LED Illumination. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSLH-2.5 L
In Commercial Distribution

  • 09348227000092 ()
VSLH-2.5 L

  • Surgical binoculars, reusable

VorOtek O Scope - 09348227000023

VorOtek O Scope - HeadBand - 2D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 2 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSOH-2D
In Commercial Distribution

  • 09348227000023 ()
VSOH-2D

  • Surgical binoculars, reusable

VorOtek O Scope - 09348227000016

VorOtek O Scope - SpecFrame - 2D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 2 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
VOROTEK PTY LTD
VSOS-2D
In Commercial Distribution

  • 09348227000016 ()
VSOS-2D

  • Surgical binoculars, reusable

ESCHENBACH LOUPE - 00192896019324

ESCHENBACH LOUPE
SONTEC INSTRUMENTS, INC.
17-1111
In Commercial Distribution

  • 00192896019324 ()
17-1111

  • Direct ophthalmoscope

SuperVu XL Advantage 3.5x, at 46cm working distanc - 04045396160804

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3982-635
In Commercial Distribution

  • 04045396160804 ()
3982-635

  • Surgical binoculars, reusable

SuperVu XL Advantage 3.5x, at 42cm working distanc - 04045396160774

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3981-635
In Commercial Distribution

  • 04045396160774 ()
3981-635

  • Surgical binoculars, reusable

SuperVu XL Advantage 3.5x, at 34cm working distanc - 04045396160743

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3980-635
In Commercial Distribution

  • 04045396160743 ()
3980-635

  • Surgical binoculars, reusable

SuperVu Hi-Res Galilean 3.0x, at 46cm working dist - 04045396160729

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3972-630
In Commercial Distribution

  • 04045396160729 ()
3972-630

  • Surgical binoculars, reusable

SuperVu Galilean 2.5x, at 46cm working distance - 04045396160668

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3962-625
In Commercial Distribution

  • 04045396160668 ()
3962-625

  • Surgical binoculars, reusable

SuperVu Galilean 2.0x, at 46cm working distance - 04045396160651

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3962-620
In Commercial Distribution

  • 04045396160651 ()
3962-620

  • Surgical binoculars, reusable

SuperVu Galilean 3.0x, at 42cm working distance - 04045396160644

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3961-630
In Commercial Distribution

  • 04045396160644 ()
3961-630

  • Surgical binoculars, reusable

SuperVu Galilean 2.5x, at 42cm working distance - 04045396160637

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3961-625
In Commercial Distribution

  • 04045396160637 ()
3961-625

  • Surgical binoculars, reusable

SuperVu Galilean 3.0x, at 34cm working distance - 04045396160620

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3960-630
In Commercial Distribution

  • 04045396160620 ()
3960-630

  • Surgical binoculars, reusable

SuperVu Galilean 2.5x, at 34 cm working distance - 04045396160613

Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3960-625
In Commercial Distribution

  • 04045396160613 ()
3960-625

  • Surgical binoculars, reusable

POLARISATION FILTER P2 - 04053755181148

No Description
Heine Optotechnik GmbH & Co. KG
FOR HR LOUPES
In Commercial Distribution

  • 04053755181148 ()
C-000.32.529

  • Surgical binoculars, reusable

HR binoculare loupe 2,5x/340 mm with - 04053755132867

cover and loupe holder attachment for HighLite, 1 piece
Spiggle & Theis Medizintechnik GmbH
10-120-01
In Commercial Distribution

  • 04053755132867 ()
10-120-01

  • Surgical binoculars, reusable

Binocular loupe, 2,5 x magnification - 04053755118922

working distance 340 mm, in case and glasses, incl. holding band & cleaning
Spiggle & Theis Medizintechnik GmbH
10-140-00
In Commercial Distribution

  • 04053755118922 ()
10-140-00

  • Surgical binoculars, reusable

STERILISABLE SWIVEL LEVERS - 04053755118731

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755118731 ()
C-000.32.551

  • Surgical binoculars, reusable

PROTECTIVE LENSES - 04053755118663

No Description
Heine Optotechnik GmbH & Co. KG
FOR HR LOUPES
In Commercial Distribution

  • 04053755118663 ()
C-000.32.526

  • Surgical binoculars, reusable

CLOSE-UP LENSES - 04053755118625

No Description
Heine Optotechnik GmbH & Co. KG
2.5 x 340 mm
In Commercial Distribution

  • 04053755118625 ()
C-000.32.523

  • Surgical binoculars, reusable

HRP - 04053755118311

No Description
Heine Optotechnik GmbH & Co. KG
6 x 340 mm
In Commercial Distribution

  • 04053755118311 ()
C-000.32.432

  • Surgical binoculars, reusable

HRP - 04053755118304

No Description
Heine Optotechnik GmbH & Co. KG
4 x 340 mm
In Commercial Distribution

  • 04053755118304 ()
C-000.32.431

  • Surgical binoculars, reusable

HRP - 04053755118298

No Description
Heine Optotechnik GmbH & Co. KG
3.5 x 420 mm
In Commercial Distribution

  • 04053755118298 ()
C-000.32.430

  • Surgical binoculars, reusable

HR - 04053755118069

No Description
Heine Optotechnik GmbH & Co. KG
2.5 x 520 mm
In Commercial Distribution

  • 04053755118069 ()
C-000.32.567

  • Surgical binoculars, reusable

HR - 04053755118052

No Description
Heine Optotechnik GmbH & Co. KG
2.5 x 420 mm
In Commercial Distribution

  • 04053755118052 ()
C-000.32.356

  • Surgical binoculars, reusable

HR - 04053755118045

No Description
Heine Optotechnik GmbH & Co. KG
2.5 x 340 mm
In Commercial Distribution

  • 04053755118045 ()
C-000.32.355

  • Surgical binoculars, reusable

CLIP-IN CORRECTION FRAME - 04053755117888

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755117888 ()
C-000.32.309

  • Surgical binoculars, reusable

C 2.3 K - 04053755117673

No Description
Heine Optotechnik GmbH & Co. KG
450 mm
In Commercial Distribution

  • 04053755117673 ()
C-000.32.231

  • Surgical binoculars, reusable

C 2.3 K - 04053755117659

No Description
Heine Optotechnik GmbH & Co. KG
340 mm
In Commercial Distribution

  • 04053755117659 ()
C-000.32.230

  • Surgical binoculars, reusable

C 2.3 - 04053755117635

No Description
Heine Optotechnik GmbH & Co. KG
450 mm
In Commercial Distribution

  • 04053755117635 ()
C-000.32.202

  • Surgical binoculars, reusable

PROTECTIVE LENSES - 04053755117604

No Description
Heine Optotechnik GmbH & Co. KG
FOR C 2.3 LOUPES
In Commercial Distribution

  • 04053755117604 ()
C-000.32.097

  • Surgical binoculars, reusable

C 2.3 - 04053755117567

No Description
Heine Optotechnik GmbH & Co. KG
340 mm
In Commercial Distribution

  • 04053755117567 ()
C-000.32.039

  • Surgical binoculars, reusable

PROTECTIVE LENSES - 04053755117550

No Description
Heine Optotechnik GmbH & Co. KG
FOR HRP LOUPES
In Commercial Distribution

  • 04053755117550 ()
C-000.32.027

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780279891

Integra® Miltex® Portable Battery Pack for LED Loupes Light Unit with Belt Clip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15060
In Commercial Distribution

  • H834150600 ()
  • 10381780279891 ()
15060

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780279860

Integra® Miltex® LED Loupes Light Unit With Mount Attachment for Miltex Loupes
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15050
In Commercial Distribution

  • H834150500 ()
  • 10381780279860 ()
15050

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462712

Integra® Miltex® Replacement Loupes Protective Caps, for Magnification 3.0X
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5029
In Commercial Distribution

  • H834150290 ()
  • 10381780462712 ()
1-5029

  • Surgical binoculars, reusable
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