Identity
- Trade Name
- Dovideq LeakControl Device FDA UDI
- Generic Name
- Invasive medical device leak tester, electrical FDA UDI
- Device Name
- The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope. FDA UDI
- Model / Reference
- T11-ASY-LEAKCONTROL FDA UDI
- Description
- The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope. FDA UDI
Identifiers
- Catalog Number
- T11-ASY-LEAKCONTROL FDA UDI
- Primary DI / UDI-DI
- 00816185001127 FDA UDI
- FDA Product Code
- FCY FDA UDI
- GMDN Term
- Invasive medical device leak tester, electrical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive medical device leak tester, electrical
Dovideq LeakControl Device by Torvan Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive medical device leak tester, electrical.
- Zutron Medical — ZUTRON MEDICAL, L.L.C. · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
- Zutron Medical — ZUTRON MEDICAL, L.L.C. · Class I
- MAINTENANCE UNIT — Olympus Medical Systems Corporation · Class II
- List of Compatible Endoscopes — Olympus Medical Systems Corporation · Class II
- ZUTRON — PENTAX of America, Inc. · Class I
- ZUTRON — PENTAX of America, Inc. · Class I
- AUTOMATED ENDOSCOPE LEAK TESTER — Olympus Medical Systems Corporation · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Torvan Medical Inc
Sources (1)
- FDA UDI d96cc5f3-8780-4958-8b10-a41d7f29bef2 34 fields · synced May 30, 2026