FDA.reportPublic FDA data

Nike

Primary DI
00840331296440
Brand
Nike
Company
BURLINGTON MEDICAL, LLC
Model
EW-0004-SV
Device description
BRAZEN BOOST GLASSES, SINGLE VISION, .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
00840331296440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840331296440008403312964408403312964400840331296440

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
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
00840331296617NikeBURLINGTON MEDICAL, LLCIWS2024-04-12