Identity
- Trade Name
- Virtuosaph Havester - Japan Only FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Model / Reference
- MCVS550HVJ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00699753021075 FDA UDI
- 510(k) Number
- K083194 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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: Endoscopic electrosurgical electrode, bipolar, single-use
Virtuosaph Havester - Japan Only by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical electrode, bipolar, single-use.
- Olympus — Olympus Winter & Ibe GmbH · Class II
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- ACE — ACE MEDICAL DEVICES PRIVATE LIMITED · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- ACE — ACE MEDICAL DEVICES PRIVATE LIMITED · Class II
Cleared under the same submission
K083194 also covers:
- Bipolar Cord, Reusable — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
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 Cardiovascular Systems Corporation
Sources (1)
- FDA UDI 24efe9a7-8055-411f-a993-604269eee262 33 fields · synced Jun 9, 2026