Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- IRIS BIPOLAR FORCEPS, 3-1/2", .4MM STR TIP FDA UDI
- Model / Reference
- 13-1814 FDA UDI
- Description
- IRIS BIPOLAR FORCEPS, 3-1/2", .4MM STR TIP FDA UDI
Identifiers
- Catalog Number
- 13-1814 FDA UDI
- Primary DI / UDI-DI
- 00842180164956 FDA UDI
- 510(k) Number
- K974793 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
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- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K974793 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.
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- Active Cord Reusable Bovie — Micro-tech Usa
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
- Elmed Incorporated
Sources (1)
- FDA UDI 89e7a82e-7f39-4c72-b7e7-ada252a17fa2 36 fields · synced May 30, 2026