Health Design Polycast Cast Boot HD-CB-PC1

GUDID 20609271000401

Pediatric Black

DARCO INTERNATIONAL, INC.

Cast boot
Primary Device ID20609271000401
NIH Device Record Keycca5f193-1460-45c8-8322-ceb9cce6eee6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Design Polycast Cast Boot
Version Model NumberHD-CB-PC1
Catalog NumberHD-CB-PC1
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
GS100609271000407 [Primary]
GS110609271000404 [Package]
Contains: 00609271000407
Package: Box [12 Units]
In Commercial Distribution
GS120609271000401 [Package]
Contains: 00609271000407
Package: Case [36 Units]
In Commercial Distribution

FDA Product Code

IPGSHOE, CAST

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 Polycast Cast Boot]

20609271000456Extra-large Black
10609271000442Large Black
10609271000435Medium Black
20609271000425Small Black
20609271000418Extra-small Black
20609271000401Pediatric Black

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