FDA.reportPublic FDA data

Nord Sleeve

Primary DI
07350128490355
Brand
Nord Sleeve
Company
Nord Ability AB
Model
NORD SLEEVE 1.2 - NF34 Size 4
Device description
Prosthetic liner for protection of the limb and connection to the prosthetic socket.Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users limb and prosthetic socket thus creating suspension through vacuum.
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350128490355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350128490355073501284903557350128490355

GMDN Terms#

Term, Definition table
TermDefinition
External limb prosthesis socket linerA flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
350657054
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350128490003Nord SleeveNORD SLEEVE 1.1 - NF29 Size 1 2024-06-17
07350128490010Nord SleeveNORD SLEEVE 1.1 - NF29 Size 22024-06-17
07350128490027Nord SleeveNORD SLEEVE 1.1 - NF29 Size 32024-06-17
07350128490034Nord SleeveNORD SLEEVE 1.1 - NF29 Size 4 2024-06-17
07350128490041Nord SleeveNORD SLEEVE 1.1 - NF29 Size 5 2024-06-17
07350128490058Nord SleeveNORD SLEEVE 1.2 - NF34 Size 62024-06-17
07350128490065Nord Liner NORD LINER 2.2 - NF29 Size XL2024-06-17
07350128490072Nord Liner NORD LINER 2.2 - NF34 Size XL2024-06-17
07350128490089Nord Liner NORD LINER 2.1 - NF34 Siz 382024-06-17
07350128490096Nord Liner NORD LINER 2.1 - NF34 Size 402024-06-17
07350128490225Nord Liner NORD LINER 2.2 - NF29 Size S2024-06-17
07350128490232Nord Liner NORD LINER 2.2 - NF29 Size M2024-06-17
07350128490249Nord Liner NORD LINER 2.2 - NF29 Size M+2024-06-17
07350128490256Nord Liner NORD LINER 2.2 - NF29 Size L2024-06-17
07350128490263Nord Liner NORD LINER 2.2 - NF29 Size L+2024-06-17
07350128490324Nord SleeveNORD SLEEVE 1.2 - NF34 Size 12024-06-17
07350128490331Nord SleeveNORD SLEEVE 1.2 - NF34 Size 2 2024-06-17
07350128490348Nord SleeveNORD SLEEVE 1.2 - NF34 Size 3 2024-06-17
07350128490362Nord SleeveNORD SLEEVE 1.2 - NF34 Size 52024-06-17
07350128490379Nord LinerNORD LINER 2.1 - NF34 Size 162024-06-17

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