FDA.reportPublic FDA data

Del Medical, Inc.

Primary DI
00858340006578
Brand
Del Medical, Inc.
Company
Del Medical, Inc.
Model
Anesthesia Screen Holder Assembly
Catalog number
333102
Published
2026-09-28
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
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
00858340006578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858340006578008583400065788583400065780858340006578

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding curtainA flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material.

Regulatory Flags#

DUNS number
078671236
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00858340006202Del Medical, Inc.DM-SARM2022-04-15
00858340006479Del Medical, Inc.KA Reveal Mobi Pro2026-03-05
00858340006523Del Medical, Inc.CM-OTC18T2026-03-05
00858340006530Del Medical, Inc.DMX2026-03-05
00858340006547Del Medical, Inc.VT300 (5187)2026-03-05
00858340006486Del Medical, Inc.CM-OTC18M2024-05-09
00858340006400Del Medical, Inc.FM-OTC18T2024-03-18
00858340006417Del Medical, Inc.FM-OTC18M2024-03-18
00858340006424Del Medical, Inc.FM-FMT18T2024-03-18
00858340006431Del Medical, Inc.FM-FMT18M2024-03-18
00858340006448Del Medical, Inc.MT500-F2024-03-18
00858340006455Del Medical, Inc.MT500-EL2024-03-18
00858340006462Del Medical, Inc.MT500-EB2024-03-18
00858340006387Del Medical, Inc.VS502023-05-16
00858340006073Del Medical, Inc.DM-FWFC2022-04-15
00858340006110Del Medical, Inc.OTC18S2022-04-15
00858340006134Del Medical, Inc.EV800T2022-04-15
00858340006141Del Medical, Inc.VT300T2022-04-15
00858340006158Del Medical, Inc.DM-OTC18S2022-04-15
00858340006165Del Medical, Inc.DM-OTC18T2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015605603Rampart Defender Radiation ShieldRampart Ic, LLCEAK2026-07-17
00860015605610Rampart VanguardRampart Ic, LLCEAK2026-07-17
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