Molli

FDA UDI

Class II (US FDA UDI)

by Molli Surgical, Inc.

Identity

Trade Name: MOLLI FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: MOLLI Introducer and MOLLI Marker (12 cm, 14GA) For use with the MOLLI System Note, the Introducer is MR Unsafe, however, the implantable Marker is MR conditional. FDA UDI
Model / Reference: MS-00009 FDA UDI
Description: MOLLI Introducer and MOLLI Marker (12 cm, 14GA) For use with the MOLLI System Note, the Introducer is MR Unsafe, however, the implantable Marker is MR conditional. FDA UDI

Identifiers

Catalog Number: MM1012 FDA UDI
Primary DI / UDI-DI: 00850024195134 FDA UDI
510(k) Number: K210600 FDA UDI
FDA Product Code: NEU FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Radiological image marker, implantable

Molli by Molli Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K210600 also covers:

MOLLI — Molli Surgical, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Molli Surgical, Inc.

Sources (1)

FDA UDI 0108612d-e890-4637-ada0-e81b19e54d0c 35 fields · synced May 30, 2026