FDA.reportPublic FDA data

ENT-SURGERY HEAD REST 18143

Primary DI
06438435181430
Brand
ENT-SURGERY HEAD REST 18143
Company
Merivaara Oy
Model
ENT-SURGERY HEAD REST 18143
Catalog number
100018143
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
06438435181430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438435181430064384351814306438435181430

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
06438435205938PUSH BAR 20593PUSH BAR 205931000205932023-06-22
06438435301265BEACH CHAIR HEAD REST 30126BEACH CHAIR HEAD REST 301261000301262023-06-22
06438435301289BEACH CHAIR HELMET HEAD REST 30128BEACH CHAIR HELMET HEAD REST 301281000301282023-06-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008394De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-06-23
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
07640152573989FISSOBaitella AGFWZ2025-10-13
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
10197344072033MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
10197344120802MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
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
00615521015299ALLENHILL-ROM, INC.FWZ2023-05-31
00615521014476ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014599ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014650ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014803ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014810ALLENHILL-ROM, INC.FWZ2023-05-30
00615521031459ALLENHILL-ROM, INC.FWZ2023-05-30