Tyvek® Self Seal Pouch with STERRAD™ Chemical Indicator 75 mm x 200 mm (3" x 8")
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Tyvek® Self Seal Pouch with STERRAD™ Chemical Indicator 75 mm x 200 mm (3" x 8") EUDAMEDTyvek Self Seal Pouch FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Tyvek® Self Seal Pouches with STERRAD™ Chemical Indicator EUDAMEDTyvek® Pouches and Rolls with STERRAD™ Chemical Indicator EUDAMEDTyvek Self Seal Pouch with Sterrad Chemical Indicator 75 mm x 200 mm FDA UDI
- Model / Reference
- 12320 EUDAMEDFDA UDI
- Description
- Tyvek Self Seal Pouch with Sterrad Chemical Indicator 75 mm x 200 mm FDA UDI
Identifiers
- Catalog Number
- 12320 FDA UDI
- Primary DI / UDI-DI
- 10705037015719 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A060000000000006Q9 EUDAMED
- Unit of Use DI
- 80705037015718 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
Tyvek® Self Seal Pouch with STERRAD™ Chemical Indicator 75 mm x 200 mm (3" x 8") by Advanced Sterilization Products, Inc. — Class I — MDR, FDA UDI — listed in…
Manufacturer's product page: Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705037A060000000000006Q9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products, Inc.
- EUDAMED SRN
- US-MF-000008427
- Authorised Representative
- ASP, The Netherlands B.V. NL-AR-000002057
Sources (3)
- EUDAMED 6e0ad1db-5be0-44a9-b48b-f1e11b48d0e1 61 fields · synced Jun 18, 2026
- FDA UDI 47cf491b-c2ae-42da-809b-336aafec23b6 36 fields · synced May 30, 2026
- EUDAMED a6ddb982-1752-48ff-ba17-d9c8d669e937 61 fields · synced Jun 18, 2026