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T-DOC 5Fr Air-Charged Single Sensor Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- T-DOC 5Fr Air-Charged Single Sensor Catheter FDA UDI
- Generic Name
- Urodynamic manometric catheter, electronic, single-use FDA UDI
- Device Name
- T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet FDA UDI
- Model / Reference
- CAT595S FDA UDI
- Description
- T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10627825014868 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Urodynamic manometric catheter, electronic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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: Urodynamic manometric catheter, electronic, single-use
T-DOC 5Fr Air-Charged Single Sensor Catheter by Laborie Medical Technologies Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Urodynamic manometric catheter, electronic, single-use.
- Bard® Urodynamic Pump Tubing Set — C. R. Bard, Inc. · Class II
- Bard® Urodynamic Catheter, Single Lumen — C. R. Bard, Inc. · Class II
- Bard® Urodynamic Catheter, Triple Lumen — C. R. Bard, Inc. · Class II
- Bard® Urodynamic Catheter, Double Lumen — C. R. Bard, Inc. · Class II
- Bard® Urodynamic Catheter, Triple Lumen — C. R. Bard, Inc. · Class II
- Bard® Urodynamic Catheter, Triple Lumen — C. R. Bard, Inc. · Class II
- Bard® Urodynamic Catheter, Triple Lumen — C. R. Bard, Inc. · Class II
- Lumax TS Pro — CooperSurgical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
Sources (2)
- FDA UDI bc6326bc-0ea7-47a8-8627-48bea467a19c 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026