FDA.report

Surgical Eye Shield

Primary DI
00854428006010
Brand
Surgical Eye Shield
Company
Jardon Eye Prosthetics, Inc.
Model
Pediatric Green
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00854428006010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854428006010008544280060108544280060100854428006010

GMDN Terms

TermDefinition
Surgical eye pressure shieldA non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient). It is designed as a rigid external eye shield (e.g., goggle like) intended to adhere to the face. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
118972350
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
true
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
00854428006003Surgical Eye ShieldPediatric Orange2023-06-26
00854428006027Surgical Eye ShieldPediatric White2023-06-26
00854428006034Surgical Eye ShieldPediatric Clear2023-06-26
00854428006041Surgical Eye ShieldSmall Orange2023-06-26
00854428006058Surgical Eye ShieldSmall Green2023-06-26
00854428006065Surgical Eye ShieldSmall Clear2023-06-26
00854428006072Surgical Eye ShieldSmall Black2023-06-26
00854428006089Surgical Eye ShieldSmall White2023-06-26
00854428006096Surgical Eye ShieldMedium Orange2023-06-26
00854428006102Surgical Eye ShieldMedium Green2023-06-26
00854428006119Surgical Eye ShieldMedium Clear2023-06-26
00854428006126Surgical Eye ShieldMedium White2023-06-26
00854428006133Surgical Eye ShieldMedium Black2023-06-26
00854428006140Surgical Eye ShieldLarge Orange2023-06-26
00854428006157Surgical Eye ShieldLarge Green2023-06-26
00854428006164Surgical Eye ShieldLarge Clear2023-06-26
00854428006188Surgical Eye ShieldLarge White2023-06-26
00854428006195Lucite ConformerSmall2023-06-26
00854428006201Lucite ConformerMedium2023-06-26
00854428006218Lucite ConformerLarge2023-06-26

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