Surora 700

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: Surora 700 FDA UDI
Generic Name: Surgical helmet system FDA UDI
Device Name: Headlight Comfort Pad Kit FDA UDI
Model / Reference: 5450655000 FDA UDI
Description: Headlight Comfort Pad Kit FDA UDI

Identifiers

Catalog Number: 5450655000 FDA UDI
Primary DI / UDI-DI: 07613252203124 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Surgical helmet system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical helmet system

Surora 700 by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical helmet system.

ProneView — DUPACO, INC. · 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
TOTALSHIELD® II — Zimmer Orthopaedic Surgical Products · Class II
ProneView — DUPACO, INC. · Class I
TOTALSHIELD® — Zimmer Orthopaedic Surgical Products · Class II
TOTALSHIELD® — 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: Stryker Corp.

Sources (1)

FDA UDI 43536f90-983f-443a-90d4-ee71445edd0e 35 fields · synced Jun 8, 2026