Ultrasound Probe Cover Biopsy Needle Guide Kit

FDA UDI

Class I (US FDA UDI)

by Advance Medical Designs, Inc.

Identity

Trade Name: Ultrasound Probe Cover Biopsy Needle Guide Kit FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: Disposable Probe Cover Accessories FDA UDI
Model / Reference: 28-GG537 FDA UDI
Description: Disposable Probe Cover Accessories FDA UDI

Identifiers

Primary DI / UDI-DI: 00848340015328 FDA UDI
FDA Product Code: GDF FDA UDI
GMDN Term: Needle guide, single-use 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

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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Needle guide, single-use

Ultrasound Probe Cover Biopsy Needle Guide Kit by Advance Medical Designs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, single-use.

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Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · 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 I	Pending data

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Manufacturer

Manufacturer: Advance Medical Designs, Inc.

Sources (1)

FDA UDI 068e7d6d-7be6-4973-8979-78a6568c8588 33 fields · synced Jun 8, 2026