FDA.reportPublic FDA data

Ease-in-Shields™

Primary DI
00850036373841
Brand
Ease-in-Shields™
Company
METREX RESEARCH, LLC
Model
922269-3
Device description
Ease-in-Shields™ yellow curing
Published
2024-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850036373841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036373841008500363738418500363738410850036373841

GMDN Terms#

Term, Definition table
TermDefinition
Epiocular radiation shield, reusableAn opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.369.3698CustomerCare@Orascoptic.com

Regulatory Flags#

DUNS number
145963778
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615375014158Spark™ TruColor™910181-212026-02-09
00615375014165Spark™ TruColor™910181-222026-02-09
00615375014172Spark™ TruColor™910181-312026-02-09
00615375014189Spark™ TruColor™910181-322026-02-09
00615375014196Spark™ TruColor™910181-412026-02-09
00615375014202Spark™ TruColor™910181-422026-02-09
00615375013731Endeavour™ TruColor™ XL910177-432026-02-06
00615375013748Endeavour™ TruColor™ XL910177-442026-02-06
00615375013755Endeavour™ TruColor™ XL910177-452026-02-06
00615375013762Endeavour™ TruColor™ XL910177-462026-02-06
00615375013779Endeavour™ TruColor™ XL910177-472026-02-06
00615375013786Endeavour™ TruColor™ XL910177-482026-02-06
00615375013793Endeavour™ TruColor™ XL910177-502026-02-06
00615375013809Endeavour™ TruColor™ XL910177-612026-02-06
00615375013816Endeavour™ TruColor™ XL910177-622026-02-06
00615375013823Endeavour™ TruColor™ XL910177-632026-02-06
00615375013830Endeavour™ TruColor™ XL910177-642026-02-06
00615375013847Endeavour™ TruColor™ XL910177-652026-02-06
00615375013854Endeavour™ TruColor™ XL910177-662026-02-06
00615375013861Endeavour™ TruColor™ XL910177-672026-02-06

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