FDA.reportPublic FDA data

Ophtho-Burr®

Primary DI
00886158010029
Brand
Ophtho-Burr®
Company
Beaver-Visitec International, Inc.
Model
8550860
Device description
OPHTHO-BURR DIAMOND BURR 5.0MM REUSABLE 1/EA
Published
2022-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOGBurr, Corneal, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOGBurr, Corneal, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886158010029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886158010029008861580100298861580100290886158010029

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
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
18669068080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628693343237Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343244Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343251Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343268Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2025-02-28
00628693343091Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2024-10-31
00628693343107Amoils Epithelial ScrubberInnovative Excimer SolutionsHOG2024-10-31
10887482177522BovieASPEN SURGICAL PRODUCTS, INC.HOG2024-08-28
10887482177546BovieASPEN SURGICAL PRODUCTS, INC.HOG2024-08-28
00887482177532BovieSYMMETRY SURGICAL INC.HOG2024-08-28
00887482177556BovieSYMMETRY SURGICAL INC.HOG2024-08-28
00887482176795BovieASPEN SURGICAL PRODUCTS, INC.HOG2024-08-27
00628693343039Amoils Epithelial Scrubber Innovative Excimer SolutionsHOG2022-12-01
00628693343046Amoils Epithelial Scrubber Innovative Excimer SolutionsHOG2022-12-01
00628693343053Amoils Epithelial Scrubber Innovative Excimer SolutionsHOG2022-12-01
00841668120057BurrKATENA PRODUCTS, INC.HOG2022-11-16
00841668120064BurrKATENA PRODUCTS, INC.HOG2022-11-16
30886158010037Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010012Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010043Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00886158010036Ophtho-Burr®Beaver-Visitec International, Inc.HOG2022-01-19
00841668113103BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113110BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113127BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113141BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113158BurrKATENA PRODUCTS, INC.HOG2020-09-14
00841668113165BurrKATENA PRODUCTS, INC.HOG2020-09-14
00192896093805ALGERBRUSH HANDLESONTEC INSTRUMENTS, INC.HOG2019-03-11
00192896012615ALGERBRUSH II CORNEAL RUST RING REMOVERSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012622ALGERBRUSH II CORNEAL RUST RING REMOVERSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012646ALGERBRUSH DIAMOND FINE GRIT BURRSONTEC INSTRUMENTS, INC.HOG2018-09-18