FDA.reportPublic FDA data

Palmero Healthcare

Primary DI
00840415102551
Brand
Palmero Healthcare
Company
Palmero Healthcare LLC
Model
1964
Catalog number
1964
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415102551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415102551008404151025518404151025510840415102551

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080530675
Device count
1
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
00840415101653Palmero Healthcare, LLC197119712021-03-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756401753DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401760DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401777DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401784DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013125MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06