FDA.reportPublic FDA data

Bovie

Primary DI
10887482176815
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
0002
Device description
Eye Bubble (10/bx)
Published
2024-08-26
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

Contact Domains#

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
00887482176825PackageGS110In Commercial Distribution
10887482176815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482176825008874821768258874821768250887482176825
1088748217681510887482176815

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

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
Expiration 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
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
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
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29
00630094551937Bioseal Inc.BIOSEALHOY2024-01-29