Kiltex Corporation

GUDID 00859297006055

A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 144 per bag.

Kiltex Corporation

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

• Primary Device ID: 00859297006055
• NIH Device Record Key: 852a95f8-6ad5-44b6-a18a-60865838ab3f
• Commercial Distribution Discontinuation: 2023-09-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kiltex Corporation
• Version Model Number: 3.5UltrasoundProbeCover(144)
• Company DUNS: 024475421
• Company Name: Kiltex Corporation
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859297006055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961029

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-23
• Device Publish Date: 2016-09-13

On-Brand Devices [Kiltex Corporation]

• 00859297006079: A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection again
• 00859297006055: A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection again
• 00859297006048: A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection again
• 00859297006031: A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for protection again
• 00859297006024: A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for protection again
• 00859297006017: A non-sterile sheath 2.0cm x 20cm intended to be used as a physical barrier for protection again
• 00859297006000: A non-sterile sheath (2.0cm x 20cm) intended to be used as a physical barrier for protection aga