Jelco - LS11
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 IdentifiersDevice Id: 35019315057865
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05019315057864
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 05019315057864
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