FDA.report

Palmero Healthcare, LLC

Primary DI
00840415101653
Brand
Palmero Healthcare, LLC
Company
Palmero Healthcare LLC
Model
1971
Catalog number
1971
Device description
DIGITAL X-RAY SENSOR PROTECTOR LARGE
Published
2021-03-06
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
true

Related Records

Contact Domains

Product Codes

CodeName
EGZHolder, film, x-ray
NRUChair, Dental, Without Operative Unit

Product Code Classifications

CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840415101653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415101653008404151016538404151016530840415101653

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(203)377-6424scott@jjinstruments.com

Regulatory Flags

DUNS number
080530675
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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

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Primary DIBrandCompanyProduct codePublished
E24721301003290VistaPosition AnteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003300VistaPosition PosteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003320VistaPosition EndoDÜRR DENTAL SEEGZ2026-03-13
E24721301003330VistaPosition BitewingDÜRR DENTAL SEEGZ2026-03-13
00810126506092Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506184Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506818Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506825Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506801Visionary By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00817169029335Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00817169029861Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00371347019636Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
08404535005134Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005226Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005257Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005288Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005349Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005011Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005042Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005073Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005103Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005165Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005196Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005318Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005370Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
07898561549150Cartridge (box) containing one pot with Digital Sensor Cone PositionerMaquira Industria de Produtos Odontologicos S/AEGZ2025-09-05
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29