FDA.reportPublic FDA data

Oakley Fuel Cell Radiation Protection Glasses

Primary DI
00860004894612
Brand
Oakley Fuel Cell Radiation Protection Glasses
Company
Barrier Technologies, LLC
Model
BT000B2991
Device description
Oakley Fuel Cell X-Ray Safety Radiation Protection Glasses with Corning® Med-X® Glass 0.75mm Pb
Published
2022-08-02
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
false

Product Codes#

Code, Name table
CodeName
IWSShield, Eye, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWSShield, Eye, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004894612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004894612008600048946128600048946120860004894612

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding goggles/spectaclesA personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
621134084
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850035588895Barrier Wrap with Support Radiation Protection Apron - Pb Standard - XX-LargeBWSP-PbS-XXL2022-10-13
00850035588901Support Vest & Skirt Radiation Protection Apron - Pb Standard - SmallSPVS-PbS-SM2022-10-13
00850035588918Support Vest & Skirt Radiation Protection Apron - Pb Standard - MediumSPVS-PbS-MD2022-10-13
00850035588925Support Vest & Skirt Radiation Protection Apron - Pb Standard - LargeSPVS-PbS-LG2022-10-13
00850035588932Support Vest & Skirt Radiation Protection Apron - Pb Standard - X-LargeSPVS-PbS-XL2022-10-13
00850035588949Support Vest & Skirt Radiation Protection Apron - Pb Standard - XX-LargeSPVS-PbS-XXL2022-10-13
00850035588956Standard Vest & Skirt Radiation Protection Apron - Pb Standard - SmallSVS-PbS-SM2022-10-13
00850035588963Standard Vest & Skirt Radiation Protection Apron - Pb Standard - Medium SVS-PbS-MD2022-10-13
00850035588970Standard Vest & Skirt Radiation Protection Apron - Pb Standard - Large SVS-PbS-LG2022-10-13
00850035588987Standard Vest & Skirt Radiation Protection Apron - Pb Standard - X-LargeSVS-PbS-XL2022-10-13
00850035588994Standard Vest & Skirt Radiation Protection Apron - Pb Standard - XX-Large SVS-PbS-XXL2022-10-13
00850035588635 Standard Vest & Skirt Radiation Protection Apron - Pb Free - Small SVS-PbF-SM2022-10-12
00850035588642Standard Vest & Skirt Radiation Protection Apron - Pb Free - MediumSVS-PbF-MD2022-10-12
00850035588659 Standard Vest & Skirt Radiation Protection Apron - Pb Free - Large SVS-PbF-LG2022-10-12
00850035588666Standard Vest & Skirt Radiation Protection Apron - Pb Free - Made to Measure SVS-PbF-MTM2022-10-12
00850035588673Standard Vest & Skirt Radiation Protection Apron - Pb Free - X-Large SVS-PbF-XL2022-10-12
00850035588680Standard Vest & Skirt Radiation Protection Apron - Pb Free - XX-Large SVS-PbF-XXL2022-10-12
00850035588697Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - SmallMGF-PbF-SM2022-10-12
00850035588703 Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - MediumMGF-PbF-MD2022-10-12
00850035588710Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - LargeMGF-PbF-LG2022-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840331296310NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296327NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296334NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296341NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296358BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296365BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296372BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296389BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296396HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296402HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296419HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296426HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296433NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296440NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296457NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296464NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296471BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296488BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296495BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296501BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296518NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296525NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296532NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296549NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296556NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296563NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296570NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296587NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296594NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296600NikeBURLINGTON MEDICAL, LLCIWS2024-04-12