Cone Instruments 111460

GUDID 00850033380385

General Purpose Sterile Probe Cover, 6” x 96” with Sterile Gel and Bands

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00850033380385
• NIH Device Record Key: 291cc192-9577-4679-942a-66300af62760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cone Instruments
• Version Model Number: 111460
• Catalog Number: 111460
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033380378 [Primary]
GS1	00850033380385 [Package]; Contains: 00850033380378; Package: CASE [24 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [Cone Instruments]

• 00850033380385: General Purpose Sterile Probe Cover, 6” x 96” with Sterile Gel and Bands
• 06975085709374: Probe Cover, VIP Film, Gel, El.Bands, Cardb. 15x244cm-6"x96"