MECRON Hip-Spica U: 105-125 cm 38-820

GUDID 10609271950181

L White double-sided

DARCO INTERNATIONAL, INC.

Hip orthosis
Primary Device ID10609271950181
NIH Device Record Key70a8fb2f-305c-49f0-85ea-e9ca46b9ea61
Commercial Distribution StatusIn Commercial Distribution
Brand NameMECRON Hip-Spica U: 105-125 cm
Version Model Number38-820
Catalog Number38-820
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
GS100609271950184 [Primary]
GS110609271950181 [Package]
Contains: 00609271950184
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

IQIORTHOSIS, LIMB BRACE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-22
Device Publish Date2023-02-14

On-Brand Devices [MECRON Hip-Spica U: 105-125 cm]

10609271950204L White right
10609271950198L White left
10609271950181L White double-sided

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