FDA.reportPublic FDA data

Palmero Healthcare, LLC

Primary DI
00840415100120
Brand
Palmero Healthcare, LLC
Company
Palmero Healthcare LLC
Model
1850S
Catalog number
1850S
Device description
BITE BLOCK COVERS SIEMANS (500)
Published
2021-03-04
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
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415100120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415100120008404151001208404151001200840415100120

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
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
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
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
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151051Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151061Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151071Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151081Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151741Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151881Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151050Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151060Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151070Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151080Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09