Identity
- Trade Name
- ProGear FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- Face Shield, Full with 11" Drape, Foam Top, Elastic Headband FDA UDI
- Model / Reference
- FM89012 FDA UDI
- Description
- Face Shield, Full with 11" Drape, Foam Top, Elastic Headband FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852212003542 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
Yes
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
No
FDA UDI
Category: Face splash shield, single-use
ProGear by Prestige Ameritech — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Prestige Ameritech
Sources (1)
- FDA UDI 2b2f7783-6cb8-4cbe-896e-1d7457d7762c 34 fields · synced Jun 9, 2026