Hays Inc HS2100SS

GUDID 00860003700853

Hays Innovations Sterile Short US Probe Cover Kit

HAYS, INC.

Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00860003700853
• NIH Device Record Key: 06e21eea-1382-402b-b897-b6f142cc0974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hays Inc
• Version Model Number: HS2100SS
• Catalog Number: HS2100SS
• Company DUNS: 079906040
• Company Name: HAYS, 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003700853 [Primary]
GS1	00860003700884 [Package]; Package: Inner Case [20 Units]; In Commercial Distribution
GS1	00860003700891 [Package]; Contains: 00860003700884; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211969

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-24
• Device Publish Date: 2021-02-04

On-Brand Devices [Hays Inc]

• 00860003700808: Hays Innovations Sterile Ultrasound Probe Cover Kit
• 00860003700860: Hays Innovations Sterile Short US Probe Cover Kit
• 00860003700853: Hays Innovations Sterile Short US Probe Cover Kit