NaviCam Tether ES-US-3002

GUDID 00850015518287

Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. 2 NaviCam Stomach Capsule and NaviCam Tether. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam System.

ANX ROBOTICA CORP

Video capsule endoscopy system capsule

• Primary Device ID: 00850015518287
• NIH Device Record Key: faef845e-bdbf-43a2-b9f9-20bfbf8661a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam Tether
• Version Model Number: CEE-1
• Catalog Number: ES-US-3002
• Company DUNS: 024972857
• Company Name: ANX ROBOTICA CORP
• 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: true
• 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: 770-480-2911
• Email: tim.thomas@anxrobotics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015518287 [Primary]
GS1	10850015518284 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221608

FDA Product Code

• QKZ: Magnetically Maneuvered Capsule Endoscopy System

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: 2023-01-13
• Device Publish Date: 2023-01-05

Devices Manufactured by ANX ROBOTICA CORP

• 00850015518287 - NaviCam Tether: 2023-01-13Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. 2 NaviCam Stomach Capsule and NaviCam Tether. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam System.
• 00850015518287 - NaviCam Tether: 2023-01-13 Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the Nav
• 00850015518294 - NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System: 2023-01-13 Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. I
• 00850015518072 - NaviCam Stomach System: 2020-12-16 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System.
• 00850015518188 - NaviCam Capsule Endoscope System: 2020-12-16 DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a n
• 00850015518195 - NaviCam Capsule Endoscope System: 2020-12-16 The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic
• 00850015518201 - NaviCam Capsule Endoscope System: 2020-12-16 Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a nove
• 00850015518232 - IntraMarX 3D: 2020-12-16
• 00850015518126 - IntraMarX: 2020-07-16 The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypo