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Ultra Surgical Masks
EUDAMEDFDA UDIClass I (EU MDR)
Ref GCFBKSF2Model Face Masks and Shields
Identity
- Trade Name
- Ultra Surgical Masks EUDAMEDCrosstex Surgical Masks with Secure Fit 2.0 Technology FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- Ultra with Secure Fit 2.0 Surgical Mask, Black FDA UDI
- Model / Reference
- Face Masks and Shields EUDAMEDGCFBKSF2 EUDAMEDFDA UDI
- Description
- Ultra with Secure Fit 2.0 Surgical Mask, Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224005444 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224FaceMask&ShieldQM EUDAMED
- Unit of Use DI
- 00732224005447 EUDAMED
- 510(k) Number
- K103303 FDA UDI
- FDA Product Code
- FXX FDA UDI
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
- GMDN Term
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ultra Surgical Masks 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 4a3104a6-af3e-4879-a49a-3544ff023d27 61 fields · synced Oct 6, 2026
- FDA UDI 9c1ef117-55b7-4096-b62c-22c94ef94dbe 35 fields · synced May 29, 2026