6-Wire Halo

FDA UDI

Class II (US FDA UDI)

by Sacred Heart Medical, Inc.

Identity

Trade Name: 6-Wire Halo FDA UDI
Generic Name: Urinary stone retrieval basket, single-use FDA UDI
Device Name: 1.5 Fr, 120 cm, 6-Wire NiTi Tipless Stone Basket FDA UDI
Model / Reference: 556160 FDA UDI
Description: 1.5 Fr, 120 cm, 6-Wire NiTi Tipless Stone Basket FDA UDI

Identifiers

Catalog Number: 556160 FDA UDI
Primary DI / UDI-DI: B0325561600 FDA UDI
FDA Product Code: FFL FDA UDI
GMDN Term: Urinary stone retrieval basket, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urinary stone retrieval basket, single-use

6-Wire Halo by Sacred Heart Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Sacred Heart Medical, Inc.

Sources (1)

FDA UDI 319671f0-a08c-45ba-97c8-5dc8fbd234be 34 fields · synced Jun 8, 2026