Health Design Ankle Leg Walker HD-LWS-MM1

GUDID 20609271000814

Small Black

DARCO INTERNATIONAL, INC.

Lower-limb orthosis ankle/foot component
Primary Device ID20609271000814
NIH Device Record Key933b2a8e-0949-46ca-88db-c81635d51673
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Design Ankle Leg Walker
Version Model NumberHD-LWS-MM1
Catalog NumberHD-LWS-MM1
Company DUNS184231298
Company NameDARCO INTERNATIONAL, INC.
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 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
GS100609271000810 [Primary]
GS110609271000817 [Package]
Contains: 00609271000810
Package: Box [4 Units]
In Commercial Distribution
GS120609271000814 [Package]
Contains: 00609271000810
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

NOCSplint, extremity, non-inflatable, external, non-sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-16
Device Publish Date2023-02-08

On-Brand Devices [Health Design Ankle Leg Walker]

20609271000845Extra-Large Black
10609271000831Large Black
20609271000821Medium Black
20609271000814Small Black
10609271000800Extra-Small Black

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