KERRAPED™ All Purpose Boot KP4B

GUDID 20609271000289

XL Black Round-toe

DARCO INTERNATIONAL, INC.

Orthotic shoe, non-customized
Primary Device ID20609271000289
NIH Device Record Key46e4e705-fccf-4236-8052-f67fae801b40
Commercial Distribution StatusIn Commercial Distribution
Brand NameKERRAPED™ All Purpose Boot
Version Model NumberKP4B
Catalog NumberKP4B
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100609271000285 [Primary]
GS110609271000282 [Package]
Contains: 00609271000285
Package: Box [12 Units]
In Commercial Distribution
GS120609271000289 [Package]
Contains: 00609271000285
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 Date2023-02-16
Device Publish Date2023-02-08

On-Brand Devices [KERRAPED™ All Purpose Boot]

20609271000289XL Black Round-toe
20609271000272L Black Round-toe
10609271000268M Black Round-toe
10609271000251S Black Round-toe

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