FDA.report

Head rest

Primary DI
07350111831271
Brand
Head rest
Company
Reison Medical AB
Model
10-235-MK2
Published
2022-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07350111831271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07350111831271073501118312717350111831271

GMDN Terms

TermDefinition
Operating/examination/treatment table headrest, reusableA device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest typically made of metal and synthetic materials that incorporate a cushion or pad that provides a softer surface for the patient's head to rest upon. It is available in various shapes and sizes and will typically include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods

Method

Regulatory Flags

DUNS number
356766220
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07350111830007Accessory clamp10-3012022-04-30
07350111830014Accessory clamp10-301-UK2022-04-30
07350111830021Accessory clamp10-301-US2022-04-30
07350111830038Accessory clamp10-3022022-04-30
07350111830045Accessory clamp10-302-P2022-04-30
07350111830052Radial clamp10-3042022-04-30
07350111830069Radial clamp10-304-P2022-04-30
07350111830076Radial clamp10-3052022-04-30
07350111830083Radial clamp10-305-P2022-04-30
07350111830090Radial clamp10-305-UK2022-04-30
07350111830106Radial clamp10-305-UK-P2022-04-30
07350111830113Radial clamp10-305-US2022-04-30
07350111830120Radial clamp10-305-US-P2022-04-30
07350111830137Radial clamp MIX10-3072022-04-30
07350111830151Radial clamp MIX10-307-P2022-04-30
07350111830168Radial clamp MIX10-307-UK2022-04-30
07350111830175Radial clamp MIX10-307-UK-P2022-04-30
07350111830182Radial clamp MIX10-307-US2022-04-30
07350111830199Radial clamp MIX10-307-US-P2022-04-30
07350111830205Radial clamp UNI10-3082022-04-30

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