FDA.reportPublic FDA data

Visitec®

Primary DI
00886158010128
Brand
Visitec®
Company
Beaver-Visitec International, Inc.
Model
8590300
Device description
EYE BANDAGE GUIBOR BUBBLE BANDAGE STERILE 10/BX
Published
2022-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158010129PrimaryGS10
00886158010128Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615801012930886158010129
00886158010128008861580101288861580101280886158010128

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur system, battery-poweredAn assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18669068080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886158106609BVIOME6000UOME6000U2025-08-11
00886158034247BVIFS6000FS60002025-07-22
00886158034674BVIELP19SU1ELP19SU12025-07-22
00886158034681BVIELP19CU1ELP19CU12025-07-22
00886158037569BVIFS6001FS60012025-07-22
00886158037576BVIOME6001UOME60012025-07-22
30886158032121CustomEyes®58001721580017212024-07-01
30886158032428CustomEyes®58001713580017132024-07-01
30886158032435CustomEyes®58001764580017642024-07-01
30886158032442CustomEyes®58001711580017112024-07-01
30886158032473CustomEyes®58001706580017062024-07-01
30886158032480CustomEyes®58001737580017372024-07-01
30886158032497CustomEyes®58001753580017532024-07-01
30886158032787CustomEyes®58001809580018092024-07-01
30886158032800CustomEyes®58001775580017752024-07-01
30886158032886CustomEyes®58001774580017742024-07-01
30886158032893CustomEyes®58001825580018252024-07-01
30886158032985CustomEyes®58001836580018362024-07-01
30886158033166CustomEyes®58001865580018652024-07-01
30886158033180CustomEyes®58001818580018182024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840479203362SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
06973541158100REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
06973541158117 REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
00620974004288BetterShieldSouthmedic IncorporatedHOY2025-12-19
00757770455409Bausch + LombBausch & Lomb IncorporatedHOY2025-08-22
00883205038227Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00883205038234Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00194613026080MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026165MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026172MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026189MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
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00194613056322MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056346MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103637MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
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00194613104269MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
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00194613104337MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104979MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118723MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118730MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118907MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118914MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118921MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118938MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118945MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122546MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122553MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01