FDA.reportPublic FDA data

ANAESTHESIA SCREEN 111

Primary DI
06438435001110
Brand
ANAESTHESIA SCREEN 111
Company
Merivaara Oy
Model
ANAESTHESIA SCREEN 111
Catalog number
100000111
Device description
Operating table accessory
Published
2023-06-22
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
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
06438435001110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438435001110064384350011106438435001110

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia screenA frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.

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
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

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Primary DI, Brand, Company table
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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
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00615521014650ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014803ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014810ALLENHILL-ROM, INC.FWZ2023-05-30
00615521031459ALLENHILL-ROM, INC.FWZ2023-05-30