Duo™ Pro Wound Care shoe DP0B

GUDID 20609271999279

black (extra-small)

DARCO INTERNATIONAL, INC.

Orthotic shoe, non-customized
Primary Device ID20609271999279
NIH Device Record Keyd28ce503-9326-4591-9b91-9e74b90dd1ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuo™ Pro Wound Care shoe
Version Model NumberDP0B
Catalog NumberDP0B
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
GS100609271999275 [Primary]
GS110609271999272 [Package]
Contains: 00609271999275
Package: Box [12 Units]
In Commercial Distribution
GS120609271999279 [Package]
Contains: 00609271999275
Package: Case [36 Units]
In Commercial Distribution

FDA Product Code

KNPORTHOSIS, CORRECTIVE SHOE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-23
Device Publish Date2024-12-13

On-Brand Devices [Duo™ Pro Wound Care shoe]

20609271999323black (2X-large)
10609271999319black (extra-large)
10609271999302black (large)
20609271999293black (medium)
10609271999289black (small)
20609271999279black (extra-small)

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