← Back to catalogue

THD PressKit

FDA UDI

Class II (US FDA UDI)

by Thd Spa

Identity

Trade Name
THD PressKit FDA UDI
Generic Name
Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Device Name
THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) and an anoscope (THD n-Ano) that, in combination with the THD Anopress allows a handy and safely execution of the THD Anal manometry. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. THD n-ano is a compact and manageable anoscope with an integrated LED light, completely disposable and packed individually. The reduced diameter and the atraumatic profile make the anoscope the ideal tool for a comfortable examination for both doctor and patient. FDA UDI
Model / Reference
THD PressKit (FL ENV) FDA UDI
Description
THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) and an anoscope (THD n-Ano) that, in combination with the THD Anopress allows a handy and safely execution of the THD Anal manometry. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. THD n-ano is a compact and manageable anoscope with an integrated LED light, completely disposable and packed individually. The reduced diameter and the atraumatic profile make the anoscope the ideal tool for a comfortable examination for both doctor and patient. FDA UDI

Identifiers

Catalog Number
800146 FDA UDI
Primary DI / UDI-DI
08033737711309 FDA UDI
510(k) Number
K161785 FDA UDI
FDA Product Code
KLA FDA UDI
GMDN Term
Gastrointestinal motility manometric catheter, non-electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 165 Millimeter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI
Weight — 25 Gram FDA UDI

Category: Gastrointestinal motility manometric catheter, non-electronic

THD PressKit by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal motility manometric catheter, non-electronic.

Cleared under the same submission

K161785 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Thd Spa

Sources (1)

  • FDA UDI ef6dfce6-66d3-4726-8ee8-4d7e420a1db9 37 fields · synced Jun 1, 2026