Nord Sleeve

GUDID 07350128490331

Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users limb and prosthetic socket thus creating suspension through vacuum.

Nord Ability AB

External limb prosthesis socket liner
Primary Device ID07350128490331
NIH Device Record Key0641709a-b091-4e80-a38d-e26e21c6434a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNord Sleeve
Version Model NumberNORD SLEEVE 1.2 - NF34 Size 2
Company DUNS350657054
Company NameNord Ability AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107350128490331 [Primary]

FDA Product Code

ISSProsthesis, Thigh Socket, External Component

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-25
Device Publish Date2024-06-17

On-Brand Devices [Nord Sleeve]

07350128490362Prosthetic liner for protection of the limb and connection to the prosthetic socket. Nord Sleeve
07350128490355Prosthetic liner for protection of the limb and connection to the prosthetic socket. Nord Sleeve
07350128490348Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users li
07350128490331Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users li
07350128490324Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users li
07350128490058NORD SLEEVE 1.2 - NF34 Size 6
07350128490041Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users li
07350128490034Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users li
07350128490027Prosthetic liner for protection of the limb and connection to the prosthetic socket. Nord Sleeve
07350128490010Prosthetic liner for protection of the limb and connection to the prosthetic socket. Nord Sleeve
07350128490003Prosthetic liner for protection of the limb and connection to the prosthetic socket. Nord Sleeve

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