VerTouch Disposable Device

Primary DI
10860011786402
Brand
VerTouch Disposable Device
Company
IntuiTap Medical, Inc.
Model
012-000-P
Device description
VerTouch Disposable Device: A non-powered device intended to be used with a parent pressure imaging display unit 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 anesthesia). It consists of a hand-held frame, with an integrated piezoresistive force sensor array (electrically excited by the display unit), designed to be attached to the display unit and placed on the patient’s lumbar spine region for noninvasive tactile-force mapping. A hygienic cover/sleeve and skin marking pen are typically supplied with the device. This is a single-use 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
true
Single use
true

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
00860011786412PackageGS11In Commercial Distribution
10860011786419PackageGS16In Commercial Distribution
10860011786402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011786412008600117864128600117864120860011786412
1086001178641910860011786419
1086001178640210860011786402

GMDN Terms#

Term, Definition table
TermDefinition
Neuraxial access pressure imaging system positioner/sensorA non-powered device intended to be used with a parent pressure imaging display unit 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 consists of a hand-held frame, with an integrated piezoresistive force sensor array (electrically excited by the display unit), designed to be attached to the display unit and placed on the patient’s lumbar spine region for noninvasive tactile-force mapping. A hygienic cover/sleeve and skin marking pen are typically supplied with the device. This is a single-use 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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00860011786436IntuiTap VerTouch Reusable Monitor012-2002026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011786436IntuiTap VerTouch Reusable MonitorIntuiTap Medical, Inc.QXD2026-10-16