Product Overview

Jelco - HC04


Device Description

A non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: FYH

Device Name: Splint, Extremity, Noninflatable, External, Sterile

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.3910

Third Party Flag: N

Medical Specialty: SU


Device Identifiers

Device Id: 35019315057919

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05019315057918

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton


Device Id: 05019315057918

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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