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Ultra Gauze Non-Woven Sponges
EUDAMEDFDA UDIClass I (EU MDR)
Ref ENC4NWUModel Gauze and Sponges
Identity
- Trade Name
- Ultra Gauze Non-Woven Sponges EUDAMEDFDA UDI
- Generic Name
- Non-woven gauze pad FDA UDI
- Device Name
- Non-Woven, 4 Ply, Non-Sterile, 4" x 4" FDA UDI
- Model / Reference
- Gauze and Sponges EUDAMEDENC4NWU EUDAMEDFDA UDI
- Description
- Non-Woven, 4 Ply, Non-Sterile, 4" x 4" FDA UDI
Identifiers
- Catalog Number
- ENC4NWU FDA UDI
- Primary DI / UDI-DI
- 10732224001101 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224Gauze/SpongeJ6 EUDAMED
- Unit of Use DI
- 00732224001104 EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M0202010102 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
- GMDN Term
- Non-woven gauze pad FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 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
Ultra Gauze Non-Woven Sponges 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 | 0732224Gauze/SpongeJ6 | 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 e3a40752-f409-40ea-a1ba-6be7752fc1e1 61 fields · synced Jul 9, 2026
- FDA UDI 6cb48ff1-5678-4e97-b57a-118c22384544 35 fields · synced May 30, 2026