Identity
- Trade Name
- THORATEC®, HEARTTOUCH® TABLET AND ACCESSORIES FDA UDI
- Generic Name
- Portable computer FDA UDI
- Model / Reference
- 105400 FDA UDI
Identifiers
- Catalog Number
- 105400 FDA UDI
- Primary DI / UDI-DI
- 00813024011767 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Portable computer FDA UDI
Classification
- Device Class
- Class III 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable computer
Thoratec®, Hearttouch® Tablet And Accessories by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable computer.
- ImmersiveTouch — ImmersiveTouch, Inc. · Class II
- Iradimed — Iradimed Corporation · Class II
- emPOWER — BIONX MEDICAL TECHNOLOGIES, INC. · Class II
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc. · Class II
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc. · Class II
- AIM™ System — Advanced Bionics · Class III
- Clear Guide CORE — Clear Guide Medical · Class II
- superDimension — Covidien LP · Class II
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thoratec Corp
Sources (1)
- FDA UDI 8e03d747-0455-4485-a8bd-de163048706a 35 fields · synced May 30, 2026