Health Design Vinyl Cast Boot HD-CB-VN4

GUDID 20609271000630

Large Black

DARCO INTERNATIONAL, INC.

Cast boot
Primary Device ID20609271000630
NIH Device Record Keycfc5dbdf-b0cd-4a0f-8c84-12a687f9526e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Design Vinyl Cast Boot
Version Model NumberHD-CB-VN4
Catalog NumberHD-CB-VN4
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
GS100609271000636 [Primary]
GS110609271000633 [Package]
Contains: 00609271000636
Package: Box [12 Units]
In Commercial Distribution
GS120609271000630 [Package]
Contains: 00609271000636
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 Vinyl Cast Boot]

20609271000647Extra-Large Black
20609271000630Large Black
20609271000623Medium Black
10609271000619Small Black
20609271000609Extra-Small Black

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