IntuiTap VerTouch Reusable Monitor

Primary DI
00860011786436
Brand
IntuiTap VerTouch Reusable Monitor
Company
IntuiTap Medical, Inc.
Model
012-200
Device description
Reusable Monitor: A noninvasive electronic device intended for tactile-force mapping of the lumbar anatomy of a patient to assist a clinician in identifying anatomical landmarks for locating and marking an interspinous needle insertion site, prior to a neuraxial diagnostic or therapeutic procedure (e.g., epidural anaesthesia). It is in the form of a small screen designed to be attached to and receive signals from a hand-held frame/holder with integrated pressure-sensing sensors, and to convert the signals into a two-dimensional visual representation of the underlying vertebral anatomy. A charger and power adaptor are typically supplied with the device.
Published
2026-10-16
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
QXDSpinal Imaging System For Neuraxial Procedures

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXDSpinal Imaging System For Neuraxial ProceduresAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220009000VerTouch Spinal Imaging DeviceIntuitap Medical, Inc.2024-01-19QXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011786443PackageGS11In Commercial Distribution
00860011786436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011786443008600117864438600117864430860011786443
00860011786436008600117864368600117864360860011786436

GMDN Terms#

Term, Definition table
TermDefinition
Neuraxial access pressure imaging system display unitA noninvasive electronic device intended for tactile-force mapping of the lumbar anatomy of a patient to assist a clinician in identifying anatomical landmarks for locating and marking an interspinous needle insertion site, prior to a neuraxial diagnostic or therapeutic procedure (e.g., epidural anaesthesia). It is in the form of a small screen designed to be attached to and receive signals from a hand-held frame/holder with integrated pressure-sensing sensors, and to convert the signals into a two-dimensional visual representation of the underlying vertebral anatomy. A charger and power adaptor are typically supplied with the device.

Regulatory Flags#

DUNS number
080291153
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860011786402VerTouch Disposable Device012-000-P2026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860011786402VerTouch Disposable DeviceIntuiTap Medical, Inc.QXD2026-10-16