FDA.reportPublic FDA data

Triangle Template Kit

Primary DI
00850044606009
Brand
Triangle Template Kit
Company
Mediview Xr, Inc.
Model
XR90-CT-KIT
Device description
MediView Triangle Template Kit for use with the XR90 system.
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223125000XR90 (XR90-SYS)Mediview Xr, Inc.2023-07-13LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044606009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044606009008500446060098500446060090850044606009

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking guide, single-useA device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117407269
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044606016Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00850044606030Kit, Aurora FG Mounting Brackets, LTXR90-BRK-FG-LT2023-10-23
00850044606047Kit, Aurora FG Mounting Brackets, RTXR90-BRK-FG-RT2023-10-23
00860006066345EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
10860006066342EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
00860006066369XR90 System, LOGIQXR90-SYS-LOGIQ2025-01-02
00860006066376XR90 System, LOGIQ, Single HeadsetXR90-LQ-HMD012025-01-02
00860006066383XR90 System, LOGIQ, Upgrade KitXR90-LQ-UPGRADE2025-01-02
00850044606023EM Probe Bracket Kit, C1-5, SingleSPEC-0310XR90-PBRK-C15-012023-10-23
00850044606054XR90XR90-SYS2023-10-23
00850044606061OmnifyXROXR-SYS2023-11-01
10850044606013Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00860006066307MediScout systemMS-100-10012021-04-20

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