Scintilla SI-50

GUDID 39005531501066

ECG Electrodes

Leonhard Lang GmbH

Electrocardiographic electrode, single-use

• Primary Device ID: 39005531501066
• NIH Device Record Key: b7a99473-8cc5-4aef-a054-652397f4eae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scintilla
• Version Model Number: CT-50
• Catalog Number: SI-50
• Company DUNS: 302846407
• Company Name: Leonhard Lang GmbH
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09005531501065 [Unit of Use]
GS1	19005531501062 [Primary]
GS1	29005531501069 [Package]; Contains: 19005531501062; Package: box [40 Units]; In Commercial Distribution
GS1	39005531501066 [Package]; Contains: 29005531501069; Package: case [4 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-24

Devices Manufactured by Leonhard Lang GmbH

• 29005531000142 - SKINTACT: 2024-08-01 ECG Electrode
• 29005531001125 - SKINTACT: 2024-08-01 ECG Electrode
• 29005531000432 - SKINTACT: 2024-04-25 Pre-wired ECG Electrode
• 29005531002535 - GE Healthcare: 2023-09-22 ECG Electrode
• 29005531002542 - GE Healthcare: 2023-09-22 ECG Electrode
• 29005531002559 - GE Healthcare: 2023-09-22 Pre-wired ECG Electrode
• 29005531002566 - GE Healthcare: 2023-09-22 ECG Electrode
• 29005531002573 - GE Healthcare: 2023-09-22 ECG Electrode