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Isofluid Surgical Masks
EUDAMEDFDA UDIClass I (EU MDR)
Ref GCIPWTModel Face Masks and Shields
Identity
- Trade Name
- Isofluid Surgical Masks EUDAMEDFDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- With Fog Free Strip and Shield. ASTM Level 1, Turquoise FDA UDI
- Model / Reference
- Face Masks and Shields EUDAMEDGCIPWT EUDAMEDFDA UDI
- Description
- With Fog Free Strip and Shield. ASTM Level 1, Turquoise FDA UDI
Identifiers
- Catalog Number
- GCIPWT FDA UDI
- Primary DI / UDI-DI
- 10732224120260 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224FaceMask&ShieldQM EUDAMED
- Unit of Use DI
- 00732224120263 EUDAMED
- 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Isofluid 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 5c80f5f9-554d-458b-88e0-4be552fb624b 61 fields · synced Jul 23, 2026
- FDA UDI 43b30f4f-4613-41cf-a058-bc4b03d0f361 35 fields · synced May 30, 2026