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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
00884450411797 FDA UDI

Identifiers

Primary DI / UDI-DI
00884450411797 FDA UDI
FDA Product Code
DWO FDA UDI
GMDN Term
Bone biopsy needle 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

For individuals with bone-related conditions, the Preston device provides a precise and minimally invasive way to collect a sample from any bone of the body. This single-use instrument is designed for use in conjunction with imaging technologies such as fluoroscopy, ultrasonography, or computed tomography (CT) scans to obtain a specimen.

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 1ed45081-07f9-416f-9c60-dbe868c8fbab 32 fields · synced Jul 12, 2026