ProneView

FDA UDI

Class I (US FDA UDI)

by Dupaco, Inc.

Identity

Trade Name: ProneView FDA UDI
Generic Name: Surgical helmet system FDA UDI
Device Name: PRONEVIEW MIRROR PLATFORM Pack FDA UDI
Model / Reference: D28520CE FDA UDI
Description: PRONEVIEW MIRROR PLATFORM Pack FDA UDI

Identifiers

Catalog Number: D28520CE FDA UDI
Primary DI / UDI-DI: 10850017419220 FDA UDI
FDA Product Code: CCX FDA UDI
GMDN Term: Surgical helmet system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Category: Surgical helmet system

ProneView by Dupaco, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Flyte — Stryker Corp. · Class I
Flyte — Stryker Corp. · Class I
TotalShield® II Zippered Surgical Toga, Large — Zimmer Orthopaedic Surgical Products · Class II
TotalShield® II Zippered Surgical Toga, XL — Zimmer Orthopaedic Surgical Products · Class II
TOTALSHIELD® II — Zimmer Orthopaedic Surgical Products · Class II

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: Dupaco, Inc.

Sources (1)

FDA UDI f29cf755-83d0-4487-a5c9-d04a70412b9a 36 fields · synced May 30, 2026