FDA.reportPublic FDA data

ErgoLite

Primary DI
00840348520897
Brand
ErgoLite
Company
AADCO MEDICAL, INC.
Model
LP-EL777
Catalog number
LP-EL777
Device description
LEADFREE .5MM ERGOLITE WRAPAROUND APRON CUSTOM
Published
2022-12-07
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

Related Records

Product Codes

CodeName
EAJApron, Leaded

Product Code Classifications

CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840348520897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348520897008403485208978403485208970840348520897

GMDN Terms

TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
153603204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348529333ErgoLiteLP-EX708LP-EX7082025-02-05
00840348529326AADCOOSP-755OSP-7552025-01-22
00840348529319AADCOPS-311APS-311A2024-11-13
00840348529302AADCOPS-405SPS-405S2024-10-21
00840348529296AADCOOSP-260NFOSP-260NF2024-10-15
00840348529289ComfortLiteLP-CL800XALP-CL800XA2024-09-09
00840348526233AADCON-101N-1012022-12-15
00840348525694AADCODB-1922CF100DB-1922CF1002022-12-19
00840348525700AADCODB-1922CF1KDB-1922CF1K2022-12-19
00840348525762AADCODB-2620NDB-2620N2022-12-19
00840348525779AADCODB-2820NDB-2820N2022-12-19
00840348526806MRI-SafeNF-500NF-5002022-12-19

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G242TC5L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
00840348529333ErgoLiteAADCO MEDICAL, INC.EAJ2025-02-05
G242J23L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242J23R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
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G242JL5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JP3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JX3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JX5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JX5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JP3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JP5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JP5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JS3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JS3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JS5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13