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Preston™

FDA UDI

Class I (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Preston™ FDA UDI
Generic Name
Bone biopsy needle FDA UDI
Model / Reference
00884450412015 FDA UDI

Identifiers

Catalog Number
ML1115/B FDA UDI
Primary DI / UDI-DI
00884450412015 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Bone biopsy needle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone biopsy needle

The Preston device is a sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It's typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device in In Commercial Distribution status.

Similar devices

Also classified as Bone biopsy needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI fd0bde17-118b-4188-9f56-958d96c3a207 33 fields · synced Jul 25, 2026