FDA.reportPublic FDA data

BEACH CHAIR HELMET HEAD REST 30128

Primary DI
06438435301289
Brand
BEACH CHAIR HELMET HEAD REST 30128
Company
Merivaara Oy
Model
BEACH CHAIR HELMET HEAD REST 30128
Catalog number
100030128
Device description
Operating table accessory
Published
2023-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
06438435301289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438435301289064384353012896438435301289

GMDN Terms#

Term, Definition table
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 available in various shapes and sizes and might include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35833394611merivaara@merivaara.com

Regulatory Flags#

DUNS number
368647421
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
06438435301302BEACH CHAIR HELMET HEAD REST 30130BEACH CHAIR HELMET HEAD REST 301301000301302023-06-26
06438435601402HEAD REST 60140HEAD REST 601401000601402023-06-26
06438435601426HEAD REST 60142HEAD REST 601421000601422023-06-26
06438435001417WIDE HEAD REST 141WIDE HEAD REST 1411000001412023-06-22
06438435001424NARROW HEAD REST 142NARROW HEAD REST 1421000001422023-06-22
06438435181010HEAD REST 18101HEAD REST 181011000181012023-06-22
06438435181430ENT-SURGERY HEAD REST 18143ENT-SURGERY HEAD REST 181431000181432023-06-22
06438435205938PUSH BAR 20593PUSH BAR 205931000205932023-06-22
06438435301265BEACH CHAIR HEAD REST 30126BEACH CHAIR HEAD REST 301261000301262023-06-22
06438435601464HEAD REST ADAPTER 60146HEAD REST ADAPTER 601461000601462023-06-22
06438435601471KIDNEY AND THORAX HEAD REST 60147KIDNEY AND THORAX HEAD REST 601471000601472023-06-22
06438435125854 TOTAL KNEE STABILIZER MV-12585 TOTAL KNEE STABILIZER MV-12585 1000125852023-11-03
0643843500138790° KNEE SUPPORT 13890° KNEE SUPPORT 1381000001382023-06-26
06438435191125FEMORAL COUNTER TRACTION POST 19112FEMORAL COUNTER TRACTION POST 191121000191122023-06-26
06438435191149STIRRUP CLAMP WITH ROTATION 19114STIRRUP CLAMP WITH ROTATION 191141000191142023-06-26
06438435191187KNEE CRUTCH 19118KNEE CRUTCH 191181000191182023-06-26
06438435191200LEG REST WITH PADDING 19120LEG REST WITH PADDING 191201000191202023-06-26
06438435191248KNEE SUPPORT 19124KNEE SUPPORT 191241000191242023-06-26
06438435191262CALF SUPPORT 19126CALF SUPPORT 191261000191262023-06-26
06438435191316CHILDRENS TRACTION BOOTS19131CHILDRENS TRACTION BOOTS191311000191312023-06-26

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