FDA.reportPublic FDA data

Cushion

Primary DI
07350111832063
Brand
Cushion
Company
Reison Medical AB
Model
10-397
Published
2022-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350111832063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350111832063073501118320637350111832063

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made cushionA soft pillow or pad that is specially designed for an individual to provide support, comfort, or assist the user to fulfill a functional requirement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
356766220
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350111831103Head rest10-2302022-04-30
07350111831110Head rest10-230-B2022-04-30
07350111831127Head rest10-230-F2022-04-30
07350111831134Head rest10-230-Fdbl2022-04-30
07350111831141Head rest10-230-Mdbl2022-04-30
07350111831158Head rest10-230-NO2022-04-30
07350111831165Head rest10-230-PED2022-04-30
07350111831172Head rest10-230-Steris2022-04-30
07350111831189Head rest10-230-T2022-04-30
07350111831196Head rest10-230-Tdbl2022-04-30
07350111831219Head rest10-2312022-04-30
07350111831226Head rest10-231-T2022-04-30
07350111831233Head rest10-2322022-04-30
07350111831240Head rest10-2332022-04-30
07350111831257Head rest10-2342022-04-30
07350111831264Head rest10-234-T2022-04-30
07350111831271Head rest10-235-MK22022-04-30
07350111831288Head rest10-2372022-04-30
07350111831295Head rest10-237-Mayf2022-04-30
07350111831301Head rest10-237-T2022-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008370MorphBoard®Innovative Medical Products, IncFWZ2026-05-19
00696588008325De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-07
00696588008264De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008271De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008288De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008295De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008301De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
00696588008318De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
00810014600598SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014600666SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014600833SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014602714SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
07640152573989FISSOBaitella AGFWZ2025-10-13
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
00733657288131ATEC KIT 4 STRAPSALIMED, INC.FWZ2024-08-02
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28