FDA.reportPublic FDA data

X-GUIDE

Primary DI
00817421023552
Brand
X-GUIDE
Company
XNAV TECHNOLOGIES LLC
Model
P011543
Device description
ToolTrace Adapter Sleeve - A
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PLVDental Stereotaxic Instrument
QRYDental Navigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLVDental Stereotaxic InstrumentDental2
QRYDental Navigation SystemDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817421023552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817421023552008174210235528174210235520817421023552

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
026096247
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817421023668X-GuideP0112652026-10-14
00817421023675X-GuideP0112662026-10-14
00817421023682X-GuideP0112682026-10-14
00817421023699X-GuideP0112692026-10-14
00817421023705X-GuideP0112712026-10-14
00817421023712X-GuideP0112722026-10-14
00817421023729X-GuideP0116932026-10-14
00817421023736X-GuideP0116942026-10-14
00817421023743X-GuideP0116962026-10-14
00817421023750X-GuideP0116972026-10-14
00817421023767X-GuideP0121262026-10-14
00817421023774X-GuideP0121272026-10-14
00817421023781X-GuideP0121282026-10-14
00817421023798X-GuideP0121292026-10-14
00817421023323X-GuideP0115582026-10-13
00817421023354X-GUIDEP0115482026-10-13
00817421023545X-GUIDEP0123612026-10-13
00817421023569X-GUIDEP0115442026-10-13
00817421023576X-GUIDEP0115452026-10-13
00817421023583X-GUIDEP0115462026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817421023668X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023675X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023682X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023699X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023705X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023712X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023729X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023736X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023743X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023750X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023767X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023774X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023781X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023323X-GuideXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023323X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023354X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023354X-GUIDEXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023545X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023545X-GUIDEXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023569X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023569X-GUIDEXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023576X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023576X-GUIDEXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023583X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023583X-GUIDEXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023590X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023590X-GuideXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023613X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023613X-GuideXNAV TECHNOLOGIES LLCPLV2026-10-13