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SofTIP

FDA UDI

Class II (US FDA UDI)

by Sentreheart, Inc

Identity

Trade Name
SofTIP FDA UDI
Generic Name
Open-surgery ligator guide sheath FDA UDI
Device Name
A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device. FDA UDI
Model / Reference
Long FDA UDI
Description
A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device. FDA UDI

Identifiers

Catalog Number
6002 FDA UDI
Primary DI / UDI-DI
M95560020 FDA UDI
510(k) Number
K090385 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Open-surgery ligator guide sheath FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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 — 22.5 Centimeter FDA UDI

Category: Open-surgery ligator guide sheath

SofTIP by Sentreheart, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K090385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sentreheart, Inc

Sources (1)

  • FDA UDI cd335f02-2e88-4e5c-b908-f85cc16750c7 37 fields · synced May 30, 2026