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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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ONE - 03700483625819

No Description
MORIA SA
ROP KIT S SPECULUM/LOOP DEPRESSOR
In Commercial Distribution

  • 03700483625826 ()
  • 03700483625819 ()
17265X10

  • Ophthalmic surgical procedure kit, non-medicated, single-use

ONE - 03700483625772

No Description
MORIA SA
ROP KIT XS SPECULUM/LOOP DEPRESSOR
In Commercial Distribution

  • 03700483625789 ()
  • 03700483625772 ()
17264X10

  • Ophthalmic surgical procedure kit, non-medicated, single-use

ONE - 03700483625734

No Description
MORIA SA
ROP KIT XS SPECULUM/2IN1 DEPRESSOR
In Commercial Distribution

  • 03700483625741 ()
  • 03700483625734 ()
17263X10

  • Ophthalmic surgical procedure kit, non-medicated, single-use

ONE - 03700483625697

No Description
MORIA SA
ROP KIT XS SPECULUM/2IN1 DEPRESSOR
In Commercial Distribution

  • 03700483627141 ()
  • 03700483625697 ()
17262X10

  • Ophthalmic surgical procedure kit, non-medicated, single-use

ONE - 03700483620159

No Description
MORIA SA
ROP exam kit W/WS -L x10
In Commercial Distribution

  • 03700483620166 ()
  • 03700483620159 ()
17257X10

  • Ophthalmic surgical procedure kit, non-medicated, single-use

ONE - 03700483611287

No Description
MORIA SA
ONE - ROP EXAM. KIT - L
In Commercial Distribution

  • 03700483603459 ()
  • 03700483611287 ()
17255X20

  • Ophthalmic surgical procedure kit, non-medicated, single-use

MORIA - 03700483600182

No Description
MORIA SA
ONE - ROP EXAM. KIT - D
In Commercial Distribution

  • 03700483600182 ()
17210

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Ophthalmic surgical procedure kit, non-medicated, single-use - 03760087122190

A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
SELF-BLOCKING VITRECTOMY INFUSION AND CANNULA SET
In Commercial Distribution

  • 53760087122195 ()
  • 03760087122190 ()
S5.7020U

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Ophthalmic surgical procedure kit, non-medicated, single-use - 03760087122176

A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE VITRECTOMY SET
In Commercial Distribution

  • 53760087122171 ()
  • 03760087122176 ()
S5.7000U

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488036663

STERILE CATARACT PACK
Cardinal Health 200, LLC
SEY69CTREH
In Commercial Distribution

  • 50887488036661 ()
  • 10887488036663 ()
SEY69CTREH

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488033730

STERILE EYE PACK
Cardinal Health 200, LLC
SEY24EYRSE
In Commercial Distribution

  • 50887488033738 ()
  • 10887488033730 ()
SEY24EYRSE

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488032672

STERILE EYE MINOR PACK
Cardinal Health 200, LLC
SEY42MNSCI
In Commercial Distribution

  • 50887488032670 ()
  • 10887488032672 ()
SEY42MNSCI

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488031637

STERILE ANTERIOR SEGMENT PK
Cardinal Health 200, LLC
SEY19ANUWF
In Commercial Distribution

  • 50887488031635 ()
  • 10887488031637 ()
SEY19ANUWF

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488031477

STERILE DSC CYSTO TUR PACK
Cardinal Health 200, LLC
SBAHDCYDRA
In Commercial Distribution

  • 50887488031475 ()
  • 10887488031477 ()
SBAHDCYDRA

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059819

27 gauge Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris PC Pack
Bausch & Lomb Incorporated
BL5427MVXB
In Commercial Distribution

  • 10757770059819 ()
  • 00757770059812 ()
BL5427MVXB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059802

27 gauge Bi-Blade Vitreous Cutter Combined Posterior Mid-Field Stellaris PC Pack
Bausch & Lomb Incorporated
BL5527MVXB
In Commercial Distribution

  • 10757770059802 ()
  • 00757770059805 ()
BL5527MVXB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059796

25 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5425MVB
In Commercial Distribution

  • 10757770059796 ()
  • 00757770059799 ()
SE5425MVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059789

25 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5525MVB
In Commercial Distribution

  • 10757770059789 ()
  • 00757770059782 ()
SE5525MVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059772

25 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5425WVB
In Commercial Distribution

  • 10757770059772 ()
  • 00757770059775 ()
SE5425WVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059765

25 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5525WVB
In Commercial Distribution

  • 10757770059765 ()
  • 00757770059768 ()
SE5525WVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059758

27 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5527MVB
In Commercial Distribution

  • 10757770059758 ()
  • 00757770059751 ()
SE5527MVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059741

27 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5427MVB
In Commercial Distribution

  • 10757770059741 ()
  • 00757770059744 ()
SE5427MVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059444

20 ga Posterior Mid-Field Elite Pack
Bausch & Lomb Incorporated
SE5420M
In Commercial Distribution

  • 10757770059444 ()
  • 00757770059447 ()
SE5420M

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770058867

Adaptive Fluidics Premium MICS Pack
Bausch & Lomb Incorporated
BL5115-3
In Commercial Distribution

  • 10757770058867 ()
  • 00757770058860 ()
BL5115-3

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770058836

Adaptive Fluidics Premium Pack
Bausch & Lomb Incorporated
BL5115-1
In Commercial Distribution

  • 10757770058836 ()
  • 00757770058839 ()
BL5115-1

  • Ophthalmic surgical procedure kit, non-medicated, single-use

I² Kit for intraocular injection - B384VS05201

Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe)
Vortex Surgical, Inc.
VS0520
In Commercial Distribution

  • B384VS05201 ()
VS0520

  • Ophthalmic surgical procedure kit, non-medicated, single-use

I² Kit for intraocular injection - B384VS05101

Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe)
Vortex Surgical, Inc.
VS0510
In Commercial Distribution

  • B384VS05101 ()
VS0510

  • Ophthalmic surgical procedure kit, non-medicated, single-use

I² Kit for intraocular injection - B384VS05001

Intraocular Injection Kit - contains blade speculum and scleral marker
Vortex Surgical, Inc.
VS0500
In Commercial Distribution

  • B384VS05001 ()
VS0500

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770060037

27 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5427WVB
In Commercial Distribution

  • 10757770060037 ()
  • 00757770060030 ()
SE5427WVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770060020

27 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5527WVB
In Commercial Distribution

  • 00757770060023 ()
  • 10757770060020 ()
SE5527WVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059963

Stellaris Elite PC 23 ga. Anterior Vitrectomy
Bausch & Lomb Incorporated
SE5623AV
In Commercial Distribution

  • 00757770059966 ()
  • 10757770059963 ()
SE5623AV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059956

23 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5523WVB
In Commercial Distribution

  • 10757770059956 ()
  • 00757770059959 ()
SE5523WVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059949

23 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5523MVB
In Commercial Distribution

  • 10757770059949 ()
  • 00757770059942 ()
SE5523MVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059932

23 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5423WVB
In Commercial Distribution

  • 10757770059932 ()
  • 00757770059935 ()
SE5423WVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059925

23 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack
Bausch & Lomb Incorporated
SE5423MVB
In Commercial Distribution

  • 10757770059925 ()
  • 00757770059928 ()
SE5423MVB

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059901

Stellaris Elite PC 20 ga. Anterior Vitrectomy
Bausch & Lomb Incorporated
SE5620AV
In Commercial Distribution

  • 00757770059904 ()
  • 10757770059901 ()
SE5620AV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059529

20 ga Posterior Wide-Field Elite Pack
Bausch & Lomb Incorporated
SE5420W
In Commercial Distribution

  • 10757770059529 ()
  • 00757770059522 ()
SE5420W

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059512

25 ga Posterior Mid-Field Elite Pack
Bausch & Lomb Incorporated
SE5425MV
In Commercial Distribution

  • 10757770059512 ()
  • 00757770059430 ()
SE5425MV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059505

23 ga Posterior Wide-Field Elite Pack
Bausch & Lomb Incorporated
SE5423WV
In Commercial Distribution

  • 10757770059505 ()
  • 00757770059508 ()
SE5423WV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059482

25 ga Posterior Wide-Field Elite Pack
Bausch & Lomb Incorporated
SE5425WV
In Commercial Distribution

  • 10757770059482 ()
  • 00757770059485 ()
SE5425WV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059475

20 ga Combined Mid-Field Elite Pack
Bausch & Lomb Incorporated
SE5520M
In Commercial Distribution

  • 10757770059475 ()
  • 00757770059478 ()
SE5520M

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059451

23 ga Combined Mid-Field Elite Pack
Bausch & Lomb Incorporated
SE5523MV
In Commercial Distribution

  • 10757770059451 ()
  • 00757770059454 ()
SE5523MV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059437

25 ga Combined Mid-Field Elite Pack
Bausch & Lomb Incorporated
SE5525MV
In Commercial Distribution

  • 10757770059437 ()
  • 00757770059430 ()
SE5525MV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770059420

23 ga Posterior Mid-Field Elite Pack
Bausch & Lomb Incorporated
SE5423MV
In Commercial Distribution

  • 10757770059420 ()
  • 00757770059423 ()
SE5423MV

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770058874

Adaptive Fluidics Basic Pack
Bausch & Lomb Incorporated
BL5115-4
In Commercial Distribution

  • 10757770058874 ()
  • 00757770058877 ()
BL5115-4

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Bausch + Lomb - 10757770058850

Adaptive Fluidics Standard Pack
Bausch & Lomb Incorporated
BL5115-2
In Commercial Distribution

  • 10757770058850 ()
  • 00757770058853 ()
BL5115-2

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Procedure Pack Z8 - 07640167751389

Procedure Pack Corneal Surgery Liquid SLIM
SIE AG, Surgical Instrument Engineering
L2
In Commercial Distribution

  • 07640167751389 ()
  • 07640167751327 ()
510.700.124

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Procedure Pack Z8 - 07640167751372

Procedure Pack Corneal Surgery 10.0 SLIM
SIE AG, Surgical Instrument Engineering
10.0 CS Z8 S
In Commercial Distribution

  • 07640167751372 ()
  • 07640167751310 ()

  • Lumen/Inner Diameter: 10.0 Millimeter
510.700.123

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Procedure Pack Z8 - 07640167751365

Procedure Pack Corneal Surgery 9.5 SLIM
SIE AG, Surgical Instrument Engineering
9.5 CS Z8 S
In Commercial Distribution

  • 07640167751365 ()
  • 07640167751303 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
510.700.122

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Procedure Pack Z8 - 07640167751358

Procedure Pack Corneal Surgery 9.0 SLIM
SIE AG, Surgical Instrument Engineering
9.0 CS Z8 S
In Commercial Distribution

  • 07640167751358 ()
  • 07640167751297 ()

  • Lumen/Inner Diameter: 9.0 Millimeter
510.700.121

  • Ophthalmic surgical procedure kit, non-medicated, single-use
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