FDA.reportPublic FDA data

Symmetry Olsen

Primary DI
30841785107703
Brand
Symmetry Olsen
Company
OLSEN MEDICAL, LLC
Model
607000
Catalog number
607000
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852404000LASERSAFE EYE SHIELDSLasersafe, Inc.1985-10-04HOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841785107703PackageGS112In Commercial Distribution
00841785107702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084178510770330841785107703
00841785107702008417851077028417851077020841785107702

GMDN Terms#

Term, Definition table
TermDefinition
Laser beam eye protector, patientA protective device that is designed to be placed either under or over the patient's eyelids in order to protect the eyes from injury during laser surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079344210
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30841785113384Symmetry Surgicale2504-01e2504-012019-07-02
30841785105730Symmetry Olsen20-2650K20-2650K2016-09-06
30841785105747Symmetry Olsen20-2920HK20-2920HK2016-09-06
30841785105754Symmetry Olsen20-2920K20-2920K2016-09-06
30841785105761Symmetry Olsen20-2960HK20-2960HK2016-09-08
30841785106126Symmetry Olsen20-6920K20-6920K2016-09-08
30841785106164Symmetry Olsen30-000130-00012016-09-06
30841785106171Symmetry Olsen30-000230-00022016-09-06
30841785106188Symmetry Olsen30-000330-00032016-09-12
30841785106195Symmetry Olsen30-000430-00042016-09-12
30841785106201Symmetry Olsen30-001130-00112016-09-06
30841785106218Symmetry Olsen30-001230-00122016-09-08
30841785106225Symmetry Olsen30-001330-00132016-09-12
30841785106232Symmetry Olsen30-001430-00142016-09-08
30841785106249Symmetry Olsen30-001530-00152016-09-12
30841785106256Symmetry Olsen30-100130-10012016-09-06
30841785106263Symmetry Olsen30-100230-10022016-09-12
30841785106270Symmetry Olsen30-100330-10032016-09-12
30841785106287Symmetry Olsen30-100430-10042016-09-12
30841785106294Symmetry Olsen30-1011S30-1011S2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29
00630094551937Bioseal Inc.BIOSEALHOY2024-01-29
00630094053707Bioseal Inc.BIOSEALHOY2024-01-26
00630094053738Bioseal Inc.BIOSEALHOY2024-01-26
00630094053905Bioseal Inc.BIOSEALHOY2024-01-26