Identity
- Trade Name
- Tissue-Tek® Lab Aid® Ultra™ II FDA UDI
- Generic Name
- Endoscope transport trolley tray FDA UDI
- Device Name
- Trolley FDA UDI
- Model / Reference
- 3980 FDA UDI
- Description
- Trolley FDA UDI
Identifiers
- Catalog Number
- 3980 FDA UDI
- Primary DI / UDI-DI
- 08720177655569 FDA UDI
- FDA Product Code
- NNK FDA UDI
- GMDN Term
- Endoscope transport trolley tray FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope transport trolley tray
Tissue-Tek® Lab Aid® Ultra™ II by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope transport trolley tray.
- Oasis Biodegradable Tray — CYGNUS MEDICAL L.L.C. · Class I
- Oasis PLUS Biodegradable Scope Transport Tray with reversible lid — CYGNUS MEDICAL L.L.C. · Class I
- Oasis Biodegradable Scope Transport Tray with Reversible lid — CYGNUS MEDICAL L.L.C. · Class I
- Tissue-Tek Xpress® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek Xpress® — Sakura Finetek USA, Inc · Class I
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 3bc96e8e-3795-4d85-abac-2ced196f1dff 35 fields · synced Jun 8, 2026