FDA.reportPublic FDA data

DRAPE

Primary DI
00840186698192
Brand
DRAPE
Company
BURLINGTON MEDICAL, LLC
Model
DRP1000 DRAPE-C
Device description
DRP1000 DRAPE-C (DRAPE ONLY-CUSTOM SINGLE PIVOT), .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
00840186698192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186698192008401866981928401866981920840186698192

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding table drapeA protective device intended to be placed on/draped over part of an operating table for a radiological examination during a surgical procedure (e.g. fluoroscopy using a C-arm) to shield attending healthcare personnel from unnecessary exposure to radiation. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material which may in part be segmented into strips to allow passage of equipment under the table. This is a reusable device.

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
05055449412483KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-06-04
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