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UniTip Catheter

FDA UDI

Class II (US FDA UDI)

by Unisensor AG

Identity

Trade Name
UniTip Catheter FDA UDI
Generic Name
Gastrointestinal motility manometric catheter, electronic FDA UDI
Model / Reference
K8400-00-1587-D FDA UDI

Identifiers

Primary DI / UDI-DI
07640172972427 FDA UDI
510(k) Number
K003580 FDA UDI
FDA Product Code
FFX FDA UDI
GMDN Term
Gastrointestinal motility manometric catheter, 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 8 French FDA UDI

Category: Gastrointestinal motility manometric catheter, electronic

UniTip Catheter by Unisensor AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal motility manometric catheter, electronic.

Cleared under the same submission

K003580 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unisensor AG

Sources (1)

  • FDA UDI 7160287d-8291-432c-a865-f3ec6b3d73bd 35 fields · synced May 31, 2026