Dornier MedTech

FDA UDI

Class II (US FDA UDI)

by Dornier MedTech America, Inc.

Identity

Trade Name: Dornier MedTech FDA UDI
Generic Name: Urinary stone retrieval basket, single-use FDA UDI
Device Name: Helical Basket, 2.5 Fr diameter, 120 cm length. FDA UDI
Model / Reference: BHAL2120 FDA UDI
Description: Helical Basket, 2.5 Fr diameter, 120 cm length. FDA UDI

Identifiers

Catalog Number: 48012517 FDA UDI
Primary DI / UDI-DI: 00810116020591 FDA UDI
FDA Product Code: FGO 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

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Urinary stone retrieval basket, single-use

Dornier MedTech by Dornier MedTech America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urinary stone retrieval basket, single-use.

GYRUS ACMI — Gyrus Acmi, Inc. · Class II
GYRUS ACMI — Gyrus Acmi, Inc. · Class II
Single-use Extraction Baskets — Scivita Medical Technology Co., Ltd. · Class II
Single-use Extraction Baskets — Scivita Medical Technology Co., Ltd. · Class II
GYRUS ACMI — Gyrus Acmi, Inc. · Class II
Vantage — SACRED HEART MEDICAL, INC. · Class II
Dormia — Coloplast A/S · Class II
GYRUS ACMI — Gyrus Acmi, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dornier MedTech America, Inc.

Sources (1)

FDA UDI cd49a7cd-5e4b-47e2-8586-6cd5bd11302d 34 fields · synced Jun 9, 2026