Identity
- Trade Name
- OptiMicro FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Disposable Electrosurgical Electrode, 8cm Long Straight Tip with Retracted Insulation FDA UDI
- Model / Reference
- Needle Electrode, 8cm FDA UDI
- Description
- Disposable Electrosurgical Electrode, 8cm Long Straight Tip with Retracted Insulation FDA UDI
Identifiers
- Catalog Number
- DN-0810 FDA UDI
- Primary DI / UDI-DI
- H671DN08100 FDA UDI
- FDA Product Code
- GEI FDA UDIHGI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI884.4120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Centimeter FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
OptiMicro by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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- star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
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Cleared under the same submission
K905263 also covers:
- C-LETZ — Utah Medical Products, Inc.
- C-LETZ — Utah Medical Products, Inc.
- C-LETZ — Utah Medical Products, Inc.
- C-LETZ — Utah Medical Products, Inc.
- DXTender — Utah Medical Products, Inc.
- DXTender — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- OptiMicro — Utah Medical Products, Inc.
- OptiMicro — Utah Medical Products, Inc.
K951032 also covers:
- C-LETZ — Utah Medical Products, Inc.
- C-LETZ — Utah Medical Products, Inc.
- C-LETZ — Utah Medical Products, Inc.
- C-LETZ — Utah Medical Products, Inc.
- DXTender — Utah Medical Products, Inc.
- DXTender — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- LETZ — Utah Medical Products, Inc.
- OptiMicro — Utah Medical Products, Inc.
- OptiMicro — Utah Medical Products, 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
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 5047c882-24be-493f-9d41-d23b62f2b386 37 fields · synced Jun 9, 2026