Identity
- Trade Name
- Splash Shield Lite FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- Sold as box of 200 FDA UDI
- Model / Reference
- 4540SCMU FDA UDI
- Description
- Sold as box of 200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10781963454020 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Face splash shield, single-use
Splash Shield Lite by Berkley Medical Resources, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Face splash shield, single-use.
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- Crosstex™ — HU-FRIEDY MFG CO., LLC · Class I
- MedSource Face Shield — MEDSOURCE INTERNATIONAL 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
- Berkley Medical Resources, Inc.
Sources (1)
- FDA UDI 85b1f69a-04be-4978-9f82-08811cd291f1 33 fields · synced Jun 8, 2026