FDA.reportPublic FDA data

Weight Bearing DRP Holders

Primary DI
00860001700176
Brand
Weight Bearing DRP Holders
Company
Reina Imaging
Model
WDDR[X]
Device description
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZMStool, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZMStool, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001700176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001700176008600017001768600017001760860001700176

GMDN Terms#

Term, Definition table
TermDefinition
FootstoolA platform, with or without legs, designed for a person to stand upon to compensate for differences in height or to place the feet/legs upon for rest/support when seated. It may be conductive to reduce the risk of static electricity when used in areas such as examination rooms or operating theatres, or non-conductive.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8153568181treina@reinaimaging.com

Regulatory Flags#

DUNS number
102370137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001700107Collim-AidCA22023-06-08
00860001700169Stitching Platform with Handles/ Clear Stitching StandCSS[X]; SPH-F2023-06-08
00860001700121Trans-Former[T][#]-[Z]Digital Detector Holder2019-10-29
00860001700183Protect-A-GridP[2][X]DR[NG][Y]Premium Grid Encasement 2019-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057027171257UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
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04057027753217UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027768129UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027777473UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027896099UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027924617UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027958162UFSK-OSYS Transport- and relaxing chairUFSK-International OSYS GmbHFZM2026-03-02
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