FDA.reportPublic FDA data

Ophtho-Burr®

Primary DI
00886158010012
Brand
Ophtho-Burr®
Company
Beaver-Visitec International, Inc.
Model
8550850
Catalog number
8550850
Device description
OPHTHO-BURR DIAMOND BURR 2.5MM 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
OTC
false
Sterile
false
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
00886158010012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886158010012008861580100128861580100120886158010012

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
18669068080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
1
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
true

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
00628693343237Amoils Epithelial ScrubberInnova Medical Ophthalmics IncHOG2025-02-28
00628693343244Amoils Epithelial ScrubberInnova Medical Ophthalmics IncHOG2025-02-28
00628693343251Amoils Epithelial ScrubberInnova Medical Ophthalmics IncHOG2025-02-28
00628693343268Amoils Epithelial ScrubberInnova Medical Ophthalmics IncHOG2025-02-28
00628693343091Amoils Epithelial ScrubberInnova Medical Ophthalmics IncHOG2024-10-31
00628693343107Amoils Epithelial ScrubberInnova Medical Ophthalmics IncHOG2024-10-31
00887482177532BovieSYMMETRY SURGICAL INC.HOG2024-08-28
00887482177556BovieSYMMETRY SURGICAL INC.HOG2024-08-28
00887482176795BovieSYMMETRY SURGICAL INC.HOG2024-08-27
00628693343039Amoils Epithelial Scrubber Innova Medical Ophthalmics IncHOG2022-12-01
00628693343046Amoils Epithelial Scrubber Innova Medical Ophthalmics IncHOG2022-12-01
00628693343053Amoils Epithelial Scrubber Innova Medical Ophthalmics IncHOG2022-12-01
00841668120057BurrKATENA PRODUCTS, INC.HOG2022-11-16
00841668120064BurrKATENA PRODUCTS, INC.HOG2022-11-16
00886158010029Ophtho-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
00192896072398ALGERBRUSH II CORNEAL RUST RING REMOVER BURRSONTEC INSTRUMENTS, INC.HOG2018-09-19
00192896012615ALGERBRUSH CORNEAL RUST RING REMOVERSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012622ALGERBRUSH CORNEAL RUST RING REMOVERSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012639ALGERBRUSH BURRSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012646ALGERBRUSH PTERYGIUMSONTEC INSTRUMENTS, INC.HOG2018-09-18
00192896012653ALGERBRUSH BURRSONTEC INSTRUMENTS, INC.HOG2018-09-18