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Sani-Tube Nylon Sterilization Tubing
EUDAMEDFDA UDIClass I (EU MDR)
Ref SI3Model Sterilization Packaging
Identity
- Trade Name
- Sani-Tube Nylon Sterilization Tubing EUDAMEDSani-Tube Nylon Sterilization Tubing with Process Indicator FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- 3 inch x 100 ft roll FDA UDI
- Model / Reference
- Sterilization Packaging EUDAMEDSI3 EUDAMEDFDA UDI
- Description
- 3 inch x 100 ft roll FDA UDI
Identifiers
- Catalog Number
- SI3 FDA UDI
- Primary DI / UDI-DI
- 10732224110131 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224SterilizationPckV5 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010299 STERILISATION REELS - OTHER 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sani-Tube Nylon Sterilization Tubing 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 | 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 3805937e-abac-4a49-a335-d9ba0f7dd1c9 61 fields · synced Jun 18, 2026
- FDA UDI 068fb3ab-7170-4175-aac4-9c28d9995fe2 35 fields · synced May 24, 2026