AccessGUDID - DEVICE: X-GUIDE (00817421020797)

GUDID

Device Identifier (DI) Information

Brand Name: X-GUIDE
Version or Model: P008542
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P008542
Company Name: XNAV TECHNOLOGIES LLC

Primary DI Number: 00817421020797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026096247 *Terms of Use

Device Description: X-Guide System Software Version 2.3.0

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 [?]
K150222	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: cc1d08ef-c532-4fc5-a563-14ab91b659de
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 267-436-0414
Email: fred.cowdery@x-navtech.com

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