FDA.reportPublic FDA data

Bovie

Primary DI
00887482176795
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
0010
Device description
Burr; Opthalmic II; Power Handle
Published
2024-08-27
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950520000BURR, CORNEAL, BATTERY-POWEREDAaron Medical Industries1995-05-02HOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482176795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482176795008874821767958874821767950887482176795

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur handpiece, battery-poweredA battery-powered, hand-held rotating device designed to perform corneal, and other ophthalmic tissue, abrasion through a bur attached to its distal tip. The device typically stops if the pressure on the tissue (e.g., cornea) is beyond a pre-established limit. It is used (with appropriate burs) to clean rust rings from the cornea after the extraction of a ferrous foreign object, to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

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
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
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
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