Health Design Low Profile Cast Boot HD-CB-TP4

GUDID 10609271000534

Medium/Large Black

DARCO INTERNATIONAL, INC.

Cast boot
Primary Device ID10609271000534
NIH Device Record Keyf33d8a42-bbee-4f16-b801-d2fd46e72644
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Design Low Profile Cast Boot
Version Model NumberHD-CB-TP4
Catalog NumberHD-CB-TP4
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
GS100609271000537 [Primary]
GS110609271000534 [Package]
Contains: 00609271000537
Package: Box [12 Units]
In Commercial Distribution
GS120609271000531 [Package]
Contains: 00609271000537
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 Low Profile Cast Boot]

10609271000558Extra-Large Black
20609271000548Large Black
10609271000534Medium/Large Black
20609271000524Medium Black
20609271000517Small/Medium Black
10609271000503Small Black

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