FDA.report

Eye Shield

Primary DI
00841668124192
Brand
Eye Shield
Company
KATENA PRODUCTS, INC.
Model
K9-6000
Catalog number
K9-6000
Device description
FOX EYE SHIELD ALUMINUM
Published
2020-09-14
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

Contact Domains

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
00841668111123PrimaryGS10
00841668124192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668111123008416681111238416681111230841668111123
00841668124192008416681241928416681241920841668124192

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

Contacts

PhoneEmail
+1(973)989-1600info@katena.com
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags

DUNS number
085668598
Device count
50
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

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