FDA.report

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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HOGBurr, Corneal, Battery-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HOGBurr, Corneal, Battery-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886158010029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886158010029008861580100298861580100290886158010029

GMDN Terms

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
Ethylene Oxide

Contacts

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

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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

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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
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