FDA.reportPublic FDA data

PORTA SHIELD

Primary DI
00840186698222
Brand
PORTA SHIELD
Company
BURLINGTON MEDICAL, LLC
Model
PTSSHIELD1
Device description
"PTSSHIELD1 (DRAPE ONLY FOR PORTA SHIELD PTS1 24""L X 24""), .5mm Regular Lead "
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAKScreen, Leaded, Operator Radiation Protector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAKScreen, Leaded, Operator Radiation ProtectorRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840186698222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186698222008401866982228401866982220840186698222

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083381202
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
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
00860010101285Rampart Head ShieldRampart Ic, LLCEAK2026-04-27
04251339907669OTMAVIG GmbHEAK2026-04-14
04251339906822OTMAVIG GmbHEAK2026-02-12
04251339907263OTMAVIG GmbHEAK2026-02-12
04251339907270OTMAVIG GmbHEAK2026-02-12
04251339907287OTMAVIG GmbHEAK2026-02-12
04251339907294OTMAVIG GmbHEAK2026-02-12
04251339907409OTMAVIG GmbHEAK2026-02-12
05055449412438KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-02-09
05055449412285KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-09-10
00860010101230Sentry Radiation ShieldRampart Ic, LLCEAK2025-08-29
00860010101254Liberty Floor StandRampart Ic, LLCEAK2025-08-08
05055449409933KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-06-09
05055449412223KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-06-06
G242MB2430G209Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB3060G209Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB2430G2090Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB3060G2090Techno-AideTechno-Aide, Inc.EAK2025-05-05
00860010101209Defender Radiation ShieldRampart Ic, LLCEAK2025-04-07
00860010101247Guardian Radiation ShieldRampart Ic, LLCEAK2025-04-07
00850067930020EggNestEGG Medical, Inc.EAK2025-03-16
05055449412018KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2024-12-09
04251339906280OTMAVIG GmbHEAK2024-06-03
04251339906297OTMAVIG GmbHEAK2024-06-03
04251339906006OTMAVIG GmbHEAK2024-04-19
04251339906013OTMAVIG GmbHEAK2024-04-19
00860002090108Rampart Rampart Ic, LLCEAK2023-08-25
00860002090177Rampart Rampart Ic, LLCEAK2023-08-25
00860002090184RampartRampart Ic, LLCEAK2023-08-25
00860002090191Rampart Rampart Ic, LLCEAK2023-08-25