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Transit-Pellets

FDA UDI

Class II (US FDA UDI)

by Medifactia AB

Identity

Trade Name
Transit-Pellets FDA UDI
Generic Name
Radiological image marker, ingestible FDA UDI
Device Name
Transit-Pellets radiopaque markers. FDA UDI
Model / Reference
Radiopaque Markers FDA UDI
Description
Transit-Pellets radiopaque markers. FDA UDI

Identifiers

Primary DI / UDI-DI
07350099550010 FDA UDI
510(k) Number
K181760 FDA UDI
K222000 FDA UDI
FDA Product Code
FFX FDA UDI
GMDN Term
Radiological image marker, ingestible 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

Category: Radiological image marker, ingestible

Transit-Pellets by Medifactia AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological image marker, ingestible.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medifactia AB

Sources (1)

  • FDA UDI 5c22f980-16ea-4440-93fe-1bf6df10434a 36 fields · synced Jun 8, 2026