Inliant

Primary DI
00850049386111
Brand
Inliant
Company
Navigate Surgical Technologies Inc
Model
900010-1
Catalog number
9000101
Device description
Inliant System, US, Full Package
Published
2023-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213392000INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc.2022-02-22PLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049386111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049386111008500493861118500493861110850049386111

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

Contacts#

Phone, Email table
PhoneEmail
16046374497info@navigatesurgical.com

Regulatory Flags#

DUNS number
204920011
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049386029Inliant900007-090000702023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817421023583X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023583X-GUIDEXNAV TECHNOLOGIES LLCPLV2026-10-13
00817421023590X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023590X-GuideXNAV TECHNOLOGIES LLCPLV2026-10-13