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Duo-Check Self-Sealing Sterilization Pouches
EUDAMEDFDA UDIClass I (EU MDR)
Ref SCL816Model Sterilization Packaging
Identity
- Trade Name
- Duo-Check Self-Sealing Sterilization Pouches EUDAMEDFDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Compatible with steam and EO sterilization. With internal/external process indicators. 8 in x 16 in (20 cm x 41 cm) FDA UDI
- Model / Reference
- Sterilization Packaging EUDAMEDSCL816 EUDAMEDFDA UDI
- Description
- Compatible with steam and EO sterilization. With internal/external process indicators. 8 in x 16 in (20 cm x 41 cm) FDA UDI
Identifiers
- Catalog Number
- SCL816 FDA UDI
- Primary DI / UDI-DI
- 10732224109449 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224SterilizationPckV5 EUDAMED
- Unit of Use DI
- 00732224109442 EUDAMED
- 510(k) Number
- K941327 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
Duo-Check Self-Sealing Sterilization Pouches by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0732224SterilizationPckV5 | 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 98e27e1a-8dbc-4ce6-903f-99e73b829e24 61 fields · synced Jul 23, 2026
- FDA UDI 738a06f9-bbd9-4bff-8408-dfbd2ef9b344 37 fields · synced May 30, 2026