FDA.reportPublic FDA data

Palmero Healthcare

Primary DI
00840415114448
Brand
Palmero Healthcare
Company
Palmero Healthcare LLC
Model
29STAUPE
Catalog number
29STAUPE
Device description
Pano-Stole Apron (Approx. 30" x 12 1/2"), .3MM Lead, Taupe
Published
2023-05-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAJApron, leaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415114448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415114448008404151144488404151144480840415114448

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(203)377-6424scott@jjinstruments.com

Regulatory Flags#

DUNS number
080530675
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00840415113083Palmero Healthcare20NAVY20NAVY2023-05-08
00840415113090Palmero Healthcare20GOLD20GOLD2023-05-08
00840415113106Palmero Healthcare20RED20RED2023-05-08
00840415113113Palmero Healthcare20MNAVY20MNAVY2023-05-08
00840415113120Palmero Healthcare20MGOLD20MGOLD2023-05-08
00840415113137Palmero Healthcare20MRED20MRED2023-05-08
00840415113144Palmero Healthcare20UNAVY20UNAVY2023-05-08
00840415113151Palmero Healthcare20UGOLD20UGOLD2023-05-08
00840415113168Palmero Healthcare20URED20URED2023-05-08
00840415113175Palmero Healthcare34NAVY34NAVY2023-05-08
00840415113182Palmero Healthcare34GOLD34GOLD2023-05-08
00840415113199Palmero Healthcare34RED34RED2023-05-08
00840415113205Palmero Healthcare34MNAVY34MNAVY2023-05-08
00840415113212Palmero Healthcare34MGOLD34MGOLD2023-05-08
00840415113229Palmero Healthcare34MRED34MRED2023-05-08
00840415113236Palmero Healthcare34UNAVY34UNAVY2023-05-08
00840415113243Palmero Healthcare34UGOLD34UGOLD2023-05-08
00840415113250Palmero Healthcare34URED34URED2023-05-08
00840415113267Palmero Healthcare23BLACK23BLACK2023-05-08
00840415113274Palmero Healthcare23FORESTGREEN23FORESTGREEN2023-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G242TB3L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TB3R90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TB5L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TB5R90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TC3L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TC3R90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
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
G242J25L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242J25R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
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