Identity
- Trade Name
- Tyvek® Self Seal Pouch with STERRAD™ Chemical Indicator 150 mm x 420 mm (6" x 16½") EUDAMEDTyvek Self Seal Pouch FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator EUDAMEDTyvek Self Seal Pouch with Sterrad Chemical Indicator 150 mm x 420 mm FDA UDI
- Model / Reference
- 12342 EUDAMEDFDA UDI
- Description
- Tyvek Self Seal Pouch with Sterrad Chemical Indicator 150 mm x 420 mm FDA UDI
Identifiers
- Catalog Number
- 12342 FDA UDI
- Primary DI / UDI-DI
- 10705037015764 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A060000000000006Q9 EUDAMED
- Unit of Use DI
- 80705037015763 EUDAMED
- FDA Product Code
- FRG FDA UDIJOJ FDA UDI
- EMDN Code
- S01010201 FLAT STERILISATION POUCHES, TYVEK/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 UDI880.2800 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
Yes
Category: Sterilization packaging, single-useChemical/physical sterilization process indicator
Tyvek Self Seal Pouch by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Chemical/physical sterilization process indicator.
- 3M™ Attest™ — 3M COMPANY · Class II
- Comply™ — 3M COMPANY · Class II
- VERISURE™ — TERRAGENE S.A. · Class II
- Comply™ SteriGage™ — 3M COMPANY · Class II
- AICON — AESCULAP, INC. · Class II
- VERIFY — Albert Browne , Ltd. · Class II
- VERISURE™ — TERRAGENE S.A. · Class II
- AESCULAP — AESCULAP, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (2)
- FDA UDI 88aea6b3-86b9-4559-88d5-6c6db1c89053 36 fields · synced Jun 19, 2026
- EUDAMED 71df87a9-e632-48d2-ace7-72d32265fd99 61 fields · synced Jun 19, 2026