Identity
- Trade Name
- Tyvek™ Self-Seal Pouch FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Tyvek™ Self-Seal Pouch, 3.5"× 5.25"/ 9×13cm FDA UDI
- Model / Reference
- TSP-180 FDA UDI
- Description
- Tyvek™ Self-Seal Pouch, 3.5"× 5.25"/ 9×13cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224009008 FDA UDI
- 510(k) Number
- K123162 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tyvek™ Self-Seal Pouch by Crosstex International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International, Inc.
Sources (1)
- FDA UDI 3fe18864-b025-45a9-b1b8-1037ecf00241 36 fields · synced Jun 8, 2026