Identity
- Trade Name
- Titan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Kelly Super Long Bayonet Bipolar Forcep Overall Length 10" (254mm) Working Length 6.1" (155mm) Insulated With A With A 0.7mm Tip Angled Up 22° With Anti-Stick Tip Design FDA UDI
- Model / Reference
- 164528257040201 FDA UDI
- Description
- Kelly Super Long Bayonet Bipolar Forcep Overall Length 10" (254mm) Working Length 6.1" (155mm) Insulated With A With A 0.7mm Tip Angled Up 22° With Anti-Stick Tip Design FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817914022178 FDA UDI
- 510(k) Number
- K974593 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 — 10 Inch 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
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
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- 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
K974593 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.
- Titan — Titan Manufacturing, Inc.
- Titan — Titan Manufacturing, 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 049f4a09-5923-4b8d-ae8b-d6e646043afc 36 fields · synced Jun 8, 2026