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Premium All-Gauze Sponges
EUDAMEDFDA UDIClass I (EU MDR)
Ref ENC48Model Gauze and Sponges
Identity
- Trade Name
- Premium All-Gauze Sponges EUDAMEDPreminum All-Gauze Sponges FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- 4" x 4", 8 Ply FDA UDI
- Model / Reference
- Gauze and Sponges EUDAMEDENC48 EUDAMEDFDA UDI
- Description
- 4" x 4", 8 Ply FDA UDI
Identifiers
- Catalog Number
- ENC48 FDA UDI
- Primary DI / UDI-DI
- 10732224004287 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224Gauze/SpongeJ6 EUDAMED
- Unit of Use DI
- 00732224004280 EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M0201020102 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
- GMDN Term
- Woven gauze roll/sheet 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Premium All-Gauze 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 61c69d8b-a63c-4dcd-a33b-b8aaa629b7f5 61 fields · synced Oct 6, 2026
- FDA UDI f97d0230-aa45-49f7-b2d9-44bbdb578afb 35 fields · synced May 30, 2026