Identity
- Trade Name
- Tyvek® Roll with STERRAD™ Chemical Indicator 100 mm x 70 m (4" x 76 yds.) EUDAMEDTyvek Roll FDA UDI
- Generic Name
- Chemical/physical sterilization process indicator FDA UDI
- Device Name
- Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator EUDAMEDTyvek Roll with Sterrad Chemical Indicator 100 mm x 70 m FDA UDI
- Model / Reference
- 12410 EUDAMEDFDA UDI
- Description
- Tyvek Roll with Sterrad Chemical Indicator 100 mm x 70 m FDA UDI
Identifiers
- Catalog Number
- 12410 FDA UDI
- Primary DI / UDI-DI
- 10705037015801 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A060000000000006Q9 EUDAMED
- FDA Product Code
- JOJ FDA UDIFRG FDA UDI
- EMDN Code
- S01010201 FLAT STERILISATION POUCHES, TYVEK/PLASTIC FILM EUDAMED
- GMDN Term
- Chemical/physical sterilization process indicator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2800 FDA UDI880.6850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Sterilization packaging, single-useChemical/physical sterilization process indicator
Tyvek Roll by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (2)
- FDA UDI 98cb1553-f6e6-4226-8652-9938717c105f 36 fields · synced Jul 10, 2026
- EUDAMED e4f8701b-f1bc-4d82-9fab-919574414c67 61 fields · synced Jul 10, 2026