18L5S SMALL ARRAY LINEAR TRANSDUCER 1750488

GUDID 60889971750488

18L5 SMALL LINEAR ARRAY TRANSDUCER

CARESTREAM HEALTH, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 60889971750488
• NIH Device Record Key: a401f318-590b-4c51-9d9b-58a315f39a91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 18L5S SMALL ARRAY LINEAR TRANSDUCER
• Version Model Number: 18L5S SMALL ARRAY LINEAR TRANSDUCER
• Catalog Number: 1750488
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971750488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150342

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-13

On-Brand Devices [18L5S SMALL ARRAY LINEAR TRANSDUCER]

• 60889971750488: 18L5 SMALL LINEAR ARRAY TRANSDUCER
• 60889971734617: 18L5S SMALL ARRAY LINEAR TRANSDUCER