Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- 5 MM DIA., 34 CM BIPOLAR LAPAROSCOPIC FORCEPS, KLEPPINGER STYLE, 2-PIN CABLE CONNECTION, COMPLETE MODULAR INSTRUMENT FDA UDI
- Model / Reference
- 55034-013 FDA UDI
- Description
- 5 MM DIA., 34 CM BIPOLAR LAPAROSCOPIC FORCEPS, KLEPPINGER STYLE, 2-PIN CABLE CONNECTION, COMPLETE MODULAR INSTRUMENT FDA UDI
Identifiers
- Catalog Number
- 55034-013 FDA UDI
- Primary DI / UDI-DI
- 00842180136830 FDA UDI
- 510(k) Number
- K181173 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic 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: Endoscopic 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 Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Bipolar Clamps — SUTTER MEDIZINTECHNIK GMBH · Class IIb
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class II
Cleared under the same submission
K181173 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
- ELMED — ELMED INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI 09de1a71-b43a-4438-bbbe-533b3ef25830 36 fields · synced Jun 8, 2026