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EPIX Conical Reamer

FDA UDI

Class I (US FDA UDI)

by Epix Orthopaedics Inc.

Identity

Trade Name
EPIX Conical Reamer FDA UDI
Generic Name
Surgical power tool system handpiece, reaming, pneumatic FDA UDI
Device Name
Reamer FDA UDI
Model / Reference
5000-00150 FDA UDI
Description
Reamer FDA UDI

Identifiers

Catalog Number
5000-00150 FDA UDI
Primary DI / UDI-DI
B2215000001500 FDA UDI
FDA Product Code
HTO FDA UDI
GMDN Term
Surgical power tool system handpiece, reaming, pneumatic 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical power tool system handpiece, reaming, pneumatic

EPIX Conical Reamer by Epix Orthopaedics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system handpiece, reaming, pneumatic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epix Orthopaedics Inc.

Sources (1)

  • FDA UDI 76e690a3-9247-4708-ab38-9351790b8a10 35 fields · synced May 30, 2026