Identity
- Trade Name
- TSCD FDA UDI
- Generic Name
- Package sealing unit FDA UDI
- Device Name
- TSCD Wafers FDA UDI
- Model / Reference
- SC*W017 FDA UDI
- Description
- TSCD Wafers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987350726971 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Package sealing unit
Tscd by Terumo Corp. — 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
- TSCD® II — Terumo BCT, Inc.. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- VITEK® REVEAL™ SEALER — BIOMERIEUX , INC. · Class II
- TSCD® — Terumo BCT, Inc.. · Class II
- SCD Welding Wafer — Terumo BCT, Inc.. · Class II
- Henry Schein — HENRY SCHEIN, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Terumo Corp.
Sources (1)
- FDA UDI 984d3f34-0fb1-4bd5-b897-0f6b39e47dcd 35 fields · synced Jun 7, 2026