FDA.reportPublic FDA data

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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415101653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415101653008404151016538404151016530840415101653

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080530675
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840415100144Palmero Healthcare, LLC1915A1915A2021-03-07
00840415101646Palmero Healthcare, LLC197019702021-03-05
00840415100069Palmero Healthcare, LLC1803B1803B2021-03-04
00840415100076Palmero Healthcare, LLC1803C1803C2021-03-04
00840415100083Palmero Healthcare, LLC1803CP1803CP2021-03-04
00840415100090Palmero Healthcare, LLC1803M1803M2021-03-04
00840415100113Palmero Healthcare, LLC185018502021-03-04
00840415100120Palmero Healthcare, LLC1850S1850S2021-03-04
00840415100137Palmero Healthcare, LLC191519152021-03-04
00840415100243Palmero Healthcare, LLC1918A1918A2021-03-04
00840415100298Palmero Healthcare, LLC1865C1865C2021-03-04
00840415100304Palmero Healthcare, LLC1866C1866C2021-03-04
00840415100311Palmero Healthcare, LLC1867C1867C2021-03-04
00840415100328Palmero Healthcare, LLC190219022021-03-04
00840415100335Palmero Healthcare, LLC190119012021-03-04
00840415100342Palmero Healthcare, LLC191019102021-03-04
00840415100359Palmero Healthcare, LLC191419142021-03-04
00840415100366Palmero Healthcare, LLC1918B1918B2021-03-04
00840415101561Palmero Healthcare, LLC191219122021-03-04
00840415101578Palmero Healthcare, LLC1912B1912B2021-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221891JMUJMU DENTAL, INCEGZ2026-06-08
00840456221907JMUJMU DENTAL, INCEGZ2026-06-08
00840456221914JMUJMU DENTAL, INCEGZ2026-06-08
00840456221921JMUJMU DENTAL, INCEGZ2026-06-08
00840456221938JMUJMU DENTAL, INCEGZ2026-06-08
00840456221945JMUJMU DENTAL, INCEGZ2026-06-08
00840456222317JMUJMU DENTAL, INCEGZ2026-06-08
00840456222324JMUJMU DENTAL, INCEGZ2026-06-08
00840456222331JMUJMU DENTAL, INCEGZ2026-06-08
00840456222348JMUJMU DENTAL, INCEGZ2026-06-08
00840456222355JMUJMU DENTAL, INCEGZ2026-06-08
00840456222362JMUJMU DENTAL, INCEGZ2026-06-08
00840456221884JMUJMU DENTAL, INCEGZ2026-06-05
D125780MLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780MW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
10304040186173EssentialsHENRY SCHEIN, INC.NRU2024-08-14
10304040186180EssentialsHENRY SCHEIN, INC.NRU2024-08-14
10304040179618Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179625Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179632Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179649Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179656Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179663Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179670Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179687Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23
10304040179694Henry ScheinHENRY SCHEIN, INC.NRU2024-02-23