FDA.reportPublic FDA data

BOVIE

Primary DI
00607151000028
Brand
BOVIE
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
0002
Catalog number
0002
Device description
EYE BUBBLE
Published
2016-10-10
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
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151000025PackageGS110In Commercial Distribution
00607151000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715100002510607151000025
00607151000028006071510000286071510000280607151000028

GMDN Terms#

Term, Definition table
TermDefinition
Eye maskA mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.

Storage And Handling#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887482121078Symmetry Dingman67-591167-59112024-08-20
00887482121085Symmetry Dingman67-591267-59122024-08-20
00840113234356BovieA1204C2026-08-17
10840113234728Bovie00032026-08-17
10840113237705BovieESP62026-08-17
10840113237712BovieESP1HN2026-08-17
10840113242426Bovie00022026-08-17
10840113244635Bovie00012026-08-17
10607151008328BovieBVX-LL06T-NSBVX-LL06T-NS2016-09-13
10607151008335BovieBVX-LC04T-NSBVX-LC04T-NS2016-09-13
10607151008342BovieBVX-LB02T-NSBVX-LB02T-NS2016-09-13
10607151008366BovieBVX-LJ07T-NSBVX-LJ07T-NS2016-09-13
10607151008373BovieBVX-LH08T-NSBVX-LH08T-NS2016-09-13
10607151008380BovieBVX-LH01T-NSBVX-LH01T-NS2016-09-13
10607151008397BovieBVX-LN03T-NSBVX-LN03T-NS2016-09-13
10607151011267BovieCS-103T-SDVCS-103T-SDV2016-08-29
10607151011281BovieCS-103T-SVCS-103T-SV2016-08-29
10607151011304BovieCS103T-SVMCS103T-SVM2016-08-29
10607151011311BovieCS-105LEDCS-105LED2016-08-29
10607151011328BovieCS-105T-LEDCS-105T-LED2016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113242426BovieASPEN SURGICAL PRODUCTS, INC.HOY2026-08-17
00827989008137SAFEVIEWHealth Care Logistics, Inc.HOY2026-07-10
00860009651647KC Eye Tape - 50 PairsKelCor, LLCHOY2026-07-10
00840456222867JMUJMU DENTAL, INCHOY2026-07-07
00840456222874JMUJMU DENTAL, INCHOY2026-07-07
D125720C4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720CR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720T4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
00630094055190Bioseal Inc.BIOSEALHOY2024-01-29
00630094404721Bioseal Inc.BIOSEALHOY2024-01-29
00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
00630094540474Bioseal Inc.BIOSEALHOY2024-01-29