Identity
- Trade Name
- Titan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Blue Titanium Round Handle Bayonet Bipolar Forcep 9" (228.6mm) Irrigating And Insulated With A Gold 10mm Area With A 0.5mm Tip FDA UDI
- Model / Reference
- 283718449030101 FDA UDI
- Description
- Blue Titanium Round Handle Bayonet Bipolar Forcep 9" (228.6mm) Irrigating And Insulated With A Gold 10mm Area With A 0.5mm Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817914024226 FDA UDI
- 510(k) Number
- K974595 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 9 Inch FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
The Titan medical device is a high-end electrosurgical handpiece designed for open-surgery procedures, featuring a rigid combined electrosurgical handpiece and bipolar electrode. It provides precise control and versatility, ideal for surgeons looking to enhance their surgical outcomes. With its compact size and rechargeable design, the Titan device is perfect for both operating rooms and clinical settings.
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K974595 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.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Titan — Titan Manufacturing, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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 9e1224ec-7f4d-4ef1-9079-f085fb50ddf3 36 fields · synced Jul 31, 2026