FDA.report

Hayden Medical

Primary DI
00840319734261
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
OP23-206Y
Catalog number
OP23-206Y
Device description
Bilateral Plastic Ocular Shield with Suction Cup, large (28.5 x 26.5mm), transparent-yellow, (not for laser), autoclavable plastic, 1 each
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840319734261PrimaryGS10

GMDN Terms

TermDefinition
Radiation/mechanical corneal shield, reusableA protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags

DUNS number
618214410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24
00840319758502Hayden Medical120-126D120-126D2025-12-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840479203355SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
00840479203362SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
06973541158100REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
06973541158117 REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
00620974004288BetterShieldSouthmedic IncorporatedHOY2025-12-19
00757770455409Bausch + LombBausch & Lomb IncorporatedHOY2025-08-22
00883205038227Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00883205038234Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00194613026080MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026165MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026172MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026189MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026219MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056322MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056346MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103637MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103644MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104269MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104276MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104337MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104979MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118723MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118730MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118907MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118914MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118921MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118938MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118945MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122546MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122553MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01