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ORLocate

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name
ORLocate FDA UDI
Generic Name
Radio-frequency identification reader FDA UDI
Device Name
OrLocate Reader Box is used with the ORLocate Sponge Solution System - WiFi enabled FDA UDI
Model / Reference
ORLocate Reader Box LAN FDA UDI
Description
OrLocate Reader Box is used with the ORLocate Sponge Solution System - WiFi enabled FDA UDI

Identifiers

Catalog Number
OX223 FDA UDI
Primary DI / UDI-DI
00724995243661 FDA UDI
510(k) Number
K100551 FDA UDI
FDA Product Code
LWH FDA UDI
GMDN Term
Radio-frequency identification reader FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.2740 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radio-frequency identification reader

ORLocate by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency identification reader.

Cleared under the same submission

K100551 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steris Corporation

Sources (1)

  • FDA UDI 3bbc8c23-c4e5-4c96-96ac-c8d6cac0fe07 36 fields · synced Jun 8, 2026