FDA.reportPublic FDA data

Amoils Epithelial Scrubber

Primary DI
00628693343053
Brand
Amoils Epithelial Scrubber
Company
Innovative Excimer Solutions
Model
Hyperopic XL Pack of 25
Catalog number
AM1EX-HXLx
Device description
Amoils Epithelial Scrubber - Hyperopic XL Pack of 25
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K962989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962989000AMOILS EPITHELIAL SCRUBBERS. Percy Amoils1997-01-09HOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628693343053PrimaryGS10
00628693343022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628693343053006286933430536286933430530628693343053
00628693343022006286933430226286933430220628693343022

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

Regulatory Flags#

DUNS number
249464702
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628693343237Amoils Epithelial ScrubberAmoils Power HandleAM3DMHANDLE2025-02-28
00628693343244Amoils Epithelial ScrubberAmoils Neck MountAM3DMNECK2025-02-28
00628693343251Amoils Epithelial ScrubberAmoils Handle Charger (120V)AM3DM120V2025-02-28
00628693343268Amoils Epithelial ScrubberAmoils Handle Charger (230V)AM3DM230V2025-02-28
00628693343091Amoils Epithelial ScrubberAmoils Power Handle, Neck & Charger - Kit (120V)AM1EXPH02024-10-31
00628693343107Amoils Epithelial ScrubberAmoils Power Handle, Neck & Charger - Kit (230V)AM1EXPH12024-10-31
00628693343039Amoils Epithelial Scrubber Myopic Pack of 25AM1EX-MYOPICx2022-12-01
00628693343046Amoils Epithelial Scrubber Hyperopic Pack of 25AM1EX-HYPx2022-12-01

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
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