Identity
- Trade Name
- Titan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Round Handle Stainless Steel Bayonet Bipolar Forcep 7 3/4" (196.85mm) With A With A 1.0mm Tip Curved Down FDA UDI
- Model / Reference
- 163710339061401 FDA UDI
- Description
- Round Handle Stainless Steel Bayonet Bipolar Forcep 7 3/4" (196.85mm) With A With A 1.0mm Tip Curved Down FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817914021423 FDA UDI
- 510(k) Number
- K974594 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 196.85 Millimeter FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Titan by Titan Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
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Cleared under the same submission
K974594 also covers:
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Ambler Surgical — Ambler Surgical, LLC
- Symmetry Adson — SYMMETRY SURGICAL INC.
- Symmetry Cushing — SYMMETRY SURGICAL INC.
- Symmetry Gerald — SYMMETRY SURGICAL INC.
- Symmetry Jewelers — SYMMETRY SURGICAL INC.
- Symmetry Malis® — SYMMETRY SURGICAL INC.
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
- Titan Manufacturing, Inc.
Sources (1)
- FDA UDI 8b5da35a-b5fb-43d8-8fc4-72e7dd11a6d7 36 fields · synced Jun 8, 2026