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Disposable Face Shields
EUDAMEDFDA UDIClass I (EU MDR)
Ref GCSS9Model Face Masks and Shields
Identity
- Trade Name
- Disposable Face Shields EUDAMEDFDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- Full Length 9 in (22.9 cm), Clear FDA UDI
- Model / Reference
- Face Masks and Shields EUDAMEDGCSS9 EUDAMEDFDA UDI
- Description
- Full Length 9 in (22.9 cm), Clear FDA UDI
Identifiers
- Catalog Number
- GCSS9 FDA UDI
- Primary DI / UDI-DI
- 10732224000944 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224FaceMask&ShieldQM EUDAMED
- Unit of Use DI
- 00732224000947 EUDAMED
- FDA Product Code
- FYE FDA UDI
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
- GMDN Term
- Face splash shield, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Disposable Face Shields by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224FaceMask&ShieldQM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6d49f722-f710-4c9d-a228-4d7013e5f8cf 61 fields · synced Oct 6, 2026
- FDA UDI 7b889bde-ed6b-49f0-ba8a-b0092792f0a7 35 fields · synced May 30, 2026