Identity
- Trade Name
- Generic FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- TYVEK ROLL 6" X 100' FDA UDI
- Model / Reference
- 551436 FDA UDI
- Description
- TYVEK ROLL 6" X 100' FDA UDI
Identifiers
- Primary DI / UDI-DI
- D830551436 FDA UDI
- FDA Product Code
- KCT 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
- 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sterilization packaging, single-use
Discover the TYVEK ROLL, a single-use sterilization packaging solution designed to contain medical devices for safe and efficient use. With features like sterile containment, convenience, and ease of use, this device is ideal for various medical applications.
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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
- AMD Medicom Inc
Sources (1)
- FDA UDI ea6862ab-0d0c-4de1-b709-945f884b2238 34 fields · synced Jun 20, 2026