Aqua Liner M SA701.3M

GUDID 04260652350038

Liner to be worn over residual limb

Romedis GmbH

External limb prosthesis socket liner
Primary Device ID04260652350038
NIH Device Record Key4760fbdd-bef3-462d-ac74-12afd361d084
Commercial Distribution StatusIn Commercial Distribution
Brand NameAqua Liner M
Version Model NumberSA701.3M
Catalog NumberSA701.3M
Company DUNS341502320
Company NameRomedis GmbH
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260652350038 [Primary]

FDA Product Code

ISSProsthesis, Thigh Socket, External Component

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-10-11

Devices Manufactured by Romedis GmbH

04260652350069 - Sleeve Office12020-06-02 Sleeve to be worn over residual limb/prosthesis socket
04260652350076 - Sleeve Office22020-06-02 Sleeve worn over residual limb/socket
04260652350083 - Sleeve Office32020-06-02
04260652350090 - Sleeve Office42020-06-02 Sleeve to be worn over residual limb/socket
04260652350106 - Sleeve heavy-duty12020-06-02 sleeve worn over residual limb/socket
04260652350113 - Sleeve heavy-duty22020-06-02 sleeve worn over residual limb/socket
04260652350120 - Sleeve heavy-duty32020-06-02 sleeve worn over residual limb/socket
04260652350137 - Sleeve heavy-duty42020-06-02 sleeve worn over residual limb/socket

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