SteriShield

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: SteriShield FDA UDI
Generic Name: Face splash shield, single-use FDA UDI
Device Name: Face Guard Headgear FDA UDI
Model / Reference: 0400660000 FDA UDI
Description: Face Guard Headgear FDA UDI

Identifiers

Catalog Number: 0400-660-000 FDA UDI
Primary DI / UDI-DI: 07613154096657 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Face splash shield, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4040 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

Yes

FDA UDI

Over-the-Counter

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

Category: Face splash shield, single-use

SteriShield by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Face splash shield, single-use.

customized — Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Class I
Halyard — O&M HALYARD, INC. · Class I
Clear Choice — Southmedic Incorporated · Class I
Medical Face Shield — DENJOY DENTAL CO., LTD · Class I
No Brand — Smith & Nephew, Inc. · Class I
Clear Choice — Southmedic Incorporated · Class I
Splash Shield — BERKLEY MEDICAL RESOURCES, INC. · Class II
Crosstex™ — HU-FRIEDY MFG CO., 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 II	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI 5807a731-8908-4bd0-8802-3325665f26ba 35 fields · synced Jun 8, 2026