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 RFID Vaginal Packing, 2-inch x 5-yard, Roll, X-Ray, Sterile is used with the ORLocate Sponge Solution System. FDA UDI
Model / Reference: ORLocate Vaginal Packing FDA UDI
Description: ORLocate RFID Vaginal Packing, 2-inch x 5-yard, Roll, X-Ray, Sterile is used with the ORLocate Sponge Solution System. FDA UDI

Identifiers

Catalog Number: VAG2X5YDR FDA UDI
Primary DI / UDI-DI: 00724995221164 FDA UDI
FDA Product Code: GDY FDA UDI
NAB FDA UDI
GMDN Term: Radiopaque woven surgical sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4450 FDA UDI
878.4014 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 5 Yard FDA UDI
Width — 2 Inch 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.

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AMD-RITMED — AMD Medicom Inc · Class I
Dukal — Dukal LLC · Class I
HCS — DYAD MEDICAL SOURCING, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Steris Corporation

Sources (1)

FDA UDI 37ff83b5-beac-4b9a-b3bf-3c4a09e505c7 36 fields · synced Jun 8, 2026