Identity
- Trade Name
- TSCD®-II FDA UDI
- Generic Name
- Package sealing unit FDA UDI
- Device Name
- Terumo Sterile Tubing Welder FDA UDI
- Model / Reference
- 62000 FDA UDI
- Description
- Terumo Sterile Tubing Welder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583620001 FDA UDI
- FDA Product Code
- KSB FDA UDI
- GMDN Term
- Package sealing unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9875 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
Yes
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
No
FDA UDI
Category: Package sealing unit
Tscd®-Ii by Terumo BCT, Inc.. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Package sealing unit.
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- VITEK® REVEAL™ SEALER — BIOMERIEUX , INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- TSCD — Terumo Corp. · Class II
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
Cleared under the same submission
BK110071 also covers:
BK160108 also covers:
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
- Terumo BCT, Inc..
Sources (1)
- FDA UDI d7cc7cc7-8538-47e6-8b1e-c3081d541bdc 36 fields · synced Jun 8, 2026