FDA.reportPublic FDA data

Visitec®

Primary DI
30886158002377
Brand
Visitec®
Company
Beaver-Visitec International, Inc.
Model
581062
Catalog number
581062
Device description
CORNEAL LIGHT SHIELD 8MM L (20/SP)
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158002377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088615800237730886158002377

GMDN Terms#

Term, Definition table
TermDefinition
Retina illumination shieldA device typically made of a non-abrasive fluid-absorbing material (e.g., a sponge), intended to be placed on the surface of the cornea to shield the retina from excessive illumination during an ophthalmic procedure; it is not intended to protect the eye from exposure to harmful radiation. It is composed of material that resists the tearing or shredding of its fibres. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30886158015292Parasol®A14-200A14-2002022-02-01
30886158015315Parasol®A14-2022022-02-01
30886158015322PARASOL®A14-203A14-2032022-02-02
30886158015414Parasol®A14-202BN2022-02-01
30886158015421PARASOL®A14-203BNA14-203BN2022-02-02
30886158015544PARASOL®A14-203QLA14-203QL2022-02-02
30886158012550Ultracell40400-82016-09-19
30886158012604UltracellNS40400-82016-09-19
30886158012611UltracellS40400-82016-09-19
30886158012628Ultracell408102016-09-19
30886158012642Ultracell408002016-09-20
30886158012659Ultracell40405-82016-09-19
30886158013205UltraClean™408152016-09-19
30886158014714UltracellBS40400-82016-09-19
30886158016015Endo Optiks®OME20002016-09-30
30886158002254Visitec®5810195810192024-06-27
30886158002650Visitec®5817085817082024-06-06
30886158010358Visitec000860100086012024-06-06
00886158002321Visiwipe5810475810472025-09-10
00886158106586BVIELP19CU5ELP19CU52025-09-10

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Primary DI, Brand, Company table
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03661219436522LANDANGERLANDANGERMDM2026-07-08
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00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
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08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
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