AccessGUDID - DEVICE: Navident (07540209955846)

GUDID

Device Identifier (DI) Information

Brand Name: Navident
Version or Model: 955-ND-HPTG-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 955-ND-HPTG-001
Company Name: Claronav Inc

Primary DI Number: 07540209955846
Issuing Agency: GS1
Commercial Distribution End Date: February 23, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 207008769 *Terms of Use

Device Description: Low Speed Handpiece Tracker (HPT LS)

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:	No
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?
61496	Surgical planning/navigation-enhancement system	A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLV	Dental Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210947	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 4c8f9f8a-4887-4c48-bcf0-dd0358ec8e84
Public Version Date: February 26, 2024
Public Version Number: 2
DI Record Publish Date: March 31, 2023