FDA.reportPublic FDA data

Nike

Primary DI
00840331296594
Brand
Nike
Company
BURLINGTON MEDICAL, LLC
Model
EW-0008-NONRX
Device description
PREMIER GLASSES, NON RX, .75MM PB EQ
Published
2024-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840331296594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840331296594008403312965948403312965940840331296594

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
083381202
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197513011903Thyroid Shield BATR5BATH2024-08-26
00197513011910Thyroid Shield BATR5BATB2024-08-26
00197513011934Thyroid Shield BATR8BATH2024-08-26
00197513011941Thyroid Shield BATR8BATB2024-08-26
00197513012597TABLEPADAM3085-Q1.5-DBCBVHLA2024-11-22
00197513012016TABLEPADAM3085-Q1.5-DBCBVHLA2024-10-21
00197513011958TABLEPADSK3100-Q1.5-DBCBVHLA2024-10-21
00197513011965TABLEPADSK3100-T2.5-DBCBVHLA2024-10-21
00197513011972TABLEPADSK3100-T3-DBCBVHLA2024-10-21
00197513011989TABLEPADAM3080-Q1.5-DBCBVHLA2024-10-21
00197513011996TABLEPADAM3080-T2.5-DBCBVHLA2024-10-21
00197513012009TABLEPADAM3080-T3-DBCBVHLA2024-10-21
00197513012023TABLEPADAM3085-T2.5-DBCBVHLA2024-10-21
00197513012030TABLEPADAM3085-T3-DBCBVHLA2024-10-21
00197513012047TABLEPADSH4900-Q1.5-DBCBVHLA2024-10-21
00197513012054TABLEPADSH4900-T2.5-DBCBVHLA2024-10-21
00197513012061TABLEPADSH4900-T3-DBCBVHLA2024-10-21
00197513012078TABLEPADSK3600-Q1.5-DBCBVHLA2024-10-21
00197513012085TABLEPADSK3600-T2.5-DBCBVHLA2024-10-21
00197513012092TABLEPADSK3600-T3-DBCBVHLA2024-10-21

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
00840331296600NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296617NikeBURLINGTON MEDICAL, LLCIWS2024-04-12