GE Reusable Endocavity Needle Guide H48701MN

GUDID 20841436114077

Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare IC9 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, reusable

• Primary Device ID: 20841436114077
• NIH Device Record Key: d47a5c7a-bf5c-4b3e-bda5-41c1c36abfcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE Reusable Endocavity Needle Guide
• Version Model Number: H48701MN
• Catalog Number: H48701MN
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Width: 1.1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436111973 [Primary]
GS1	20841436114077 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875128

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: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-09-21

On-Brand Devices [GE Reusable Endocavity Needle Guide]

• 20841436114084: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
• 20841436114077: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
• 00841436110570: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
• 00841436111973: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
• 00841436113700: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar