Identity
- Trade Name
- Face shield FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Model / Reference
- SHL-001-10 FDA UDI
Identifiers
- Catalog Number
- SHL-001-10 FDA UDI
- Primary DI / UDI-DI
- 20848956002778 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Face splash shield, single-use 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
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
Yes
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
Face shield by Healthmark Industries Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Face splash shield, single-use.
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Healthmark Industries Co., Inc.
Sources (1)
- FDA UDI 6d8309df-db1f-454f-af2f-cddcff01089f 33 fields · synced Jun 6, 2026