Pro-Lite

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name: Pro-Lite FDA UDI
Generic Name: Surgical instrument guard, reusable FDA UDI
Device Name: The PRO-Lite Sterilization Tray Mat, 25-inch x 4.5-inch, is used in V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX sterilizers. FDA UDI
Model / Reference: VP0073 FDA UDI
Description: The PRO-Lite Sterilization Tray Mat, 25-inch x 4.5-inch, is used in V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX sterilizers. FDA UDI

Identifiers

Catalog Number: VP0073 FDA UDI
Primary DI / UDI-DI: 00724995002961 FDA UDI
FDA Product Code: KCT FDA UDI
GMDN Term: Surgical instrument guard, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 5 Inch FDA UDI
Length — 25 Inch FDA UDI

Category: Surgical instrument guard, reusable

Pro-Lite by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument guard, reusable.

Legion — Smith & Nephew, Inc. · Class II
Made-To-Order — TORNIER, INC. · Class I
De Soutter Medical — De Soutter Medical, Ltd. · Class I
Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Made-To-Order — TORNIER, INC. · Class I
JOURNEY II — Smith & Nephew, Inc. · Class II
LINK Instruments - Saw and drill guides — WALDEMAR LINK GmbH & Co. KG · Class I
Tornier Perform — TORNIER, INC. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Steris Corporation

Sources (1)

FDA UDI 15f65119-21f4-43ee-8615-519fca773f43 36 fields · synced Jun 8, 2026