FDA.reportPublic FDA data

Rolko

Primary DI
04260676050082
Brand
Rolko
Company
Rolko Kohlgrüber GmbH
Model
TGN-R100GR-Hr-1-55/60
Device description
handle for bed lifting pole PGFZ - patient can bring himself into upper position or can simply hold himself in postion.
Published
2023-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILZAccessories, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILZAccessories, TractionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260676050099PackageGS175In Commercial Distribution
04260676050082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260676050099042606760500994260676050099
04260676050082042606760500824260676050082

GMDN Terms#

Term, Definition table
TermDefinition
Assistive patient lifting poleA device designed as an overhead bar with a hanging handgrip above the occupant of the bed that is attached to a medical bed or secured to the wall behind the bed and used by the occupant to provide support when changing position or pulling themselves into a sitting position.

Regulatory Flags#

DUNS number
328715693
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260676050099RolkoTGN-R100GR-Hr-1-55/602023-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888912296533CHATTANOOGADJO, LLCILZ2024-08-20
00630094171470Bioseal Inc.BIOSEALILZ2023-09-18
10630094171477Bioseal Inc.BIOSEALILZ2023-09-18
00630094163604Bioseal Inc.BIOSEALILZ2023-09-13
00630094163635Bioseal Inc.BIOSEALILZ2023-09-13
00630094163642Bioseal Inc.BIOSEALILZ2023-09-13
00630094163659Bioseal Inc.BIOSEALILZ2023-09-13
00630094163666Bioseal Inc.BIOSEALILZ2023-09-13
00630094163727Bioseal Inc.BIOSEALILZ2023-09-13
10630094163601Bioseal Inc.BIOSEALILZ2023-09-13
10630094163632Bioseal Inc.BIOSEALILZ2023-09-13
10630094163649Bioseal Inc.BIOSEALILZ2023-09-13
10630094163656Bioseal Inc.BIOSEALILZ2023-09-13
10630094163663Bioseal Inc.BIOSEALILZ2023-09-13
10630094163724Bioseal Inc.BIOSEALILZ2023-09-13
04260676050099RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04719871180372EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180389EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180396EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180402EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
00888912268806CHATTANOOGADJO, LLCILZ2023-04-18
00888912268851CHATTANOOGADJO, LLCILZ2023-04-18
00888912258746CHATTANOOGADJO, LLCILZ2022-12-01
00749756022088DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022101DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022118DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022132DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022255DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756097253DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756097291DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29