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Fisturasper

FDA UDI

Class I (US FDA UDI)

by qtec CE-med GmbH

Identity

Trade Name
Fisturasper FDA UDI
Generic Name
Anal fistula circular cutter FDA UDI
Device Name
The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the outside by reaming. FDA UDI
Model / Reference
S-XL FDA UDI
Description
The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the outside by reaming. FDA UDI

Identifiers

Catalog Number
FR001 FDA UDI
Primary DI / UDI-DI
04262358420015 FDA UDI
FDA Product Code
GAC FDA UDI
GMDN Term
Anal fistula circular cutter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Anal fistula circular cutter

Fisturasper by qtec CE-med GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anal fistula circular cutter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
qtec CE-med GmbH

Sources (1)

  • FDA UDI 748602a9-c758-495d-a535-9a3cd54eab03 37 fields · synced May 29, 2026