AccessGUDID - DEVICE: NaviCam Tether (00850015518287)

GUDID

Device Identifier (DI) Information

Brand Name: NaviCam Tether
Version or Model: CEE-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES-US-3002
Company Name: ANX ROBOTICA CORP

Primary DI Number: 00850015518287
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024972857 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38068	Video capsule endoscopy system capsule	An electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKZ	Magnetically Maneuvered Capsule Endoscopy System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221608	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: faef845e-bdbf-43a2-b9f9-20bfbf8661a2
Public Version Date: January 13, 2023
Public Version Number: 1
DI Record Publish Date: January 05, 2023