Identity
- Trade Name
- Tissue-Tek® FDA UDI
- Generic Name
- Laboratory waste receptacle liner IVD FDA UDI
- Device Name
- Waste Collection Bags FDA UDI
- Model / Reference
- 4658 FDA UDI
- Description
- Waste Collection Bags FDA UDI
Identifiers
- Catalog Number
- 4658 FDA UDI
- Primary DI / UDI-DI
- 10615233078688 FDA UDI
- FDA Product Code
- IDO FDA UDI
- GMDN Term
- Laboratory waste receptacle liner IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laboratory waste receptacle liner IVD
Tissue-Tek® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory waste receptacle liner IVD.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 2898d089-5bd1-4f91-9c7a-8baaaebc2ef2 35 fields · synced May 30, 2026