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ORLocate

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name
ORLocate FDA UDI
Generic Name
Radiopaque woven surgical sponge FDA UDI
Device Name
OrLocate Locator is used with the ORLocate Sponge Solution System. FDA UDI
Model / Reference
ORLocate Locator FDA UDI
Description
OrLocate Locator is used with the ORLocate Sponge Solution System. FDA UDI

Identifiers

Catalog Number
OX202 FDA UDI
Primary DI / UDI-DI
00724995243647 FDA UDI
510(k) Number
K100551 FDA UDI
FDA Product Code
LWH FDA UDI
GMDN Term
Radiopaque woven surgical sponge 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: Radiopaque woven surgical sponge

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

Similar devices

Also classified as Radiopaque woven surgical sponge.

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 2c04b8e5-b343-4bba-b0f9-020ad8fca38d 36 fields · synced Jun 8, 2026