Health Design Ankle Leg Walker HD-LWS-MM0

GUDID 10609271000800

Extra-Small Black

DARCO INTERNATIONAL, INC.

Lower-limb orthosis ankle/foot component
Primary Device ID10609271000800
NIH Device Record Key97199b58-9756-46f9-b827-ee4d96ad5c04
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Design Ankle Leg Walker
Version Model NumberHD-LWS-MM0
Catalog NumberHD-LWS-MM0
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
GS100609271000803 [Primary]
GS110609271000800 [Package]
Contains: 00609271000803
Package: Box [4 Units]
In Commercial Distribution
GS120609271000807 [Package]
Contains: 00609271000803
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.