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Disposable Irrigating Bipolar Forceps, 8", Micro Tips

FDA UDI

Class II (US FDA UDI)

by Katalyst Surgical, Llc

Identity

Trade Name
Disposable Irrigating Bipolar Forceps, 8", Micro Tips FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
Box, International, Disposable Irrigating Bipolar Forceps, 8", Micro FDA UDI
Model / Reference
DNI8-FS FDA UDI
Description
Box, International, Disposable Irrigating Bipolar Forceps, 8", Micro FDA UDI

Identifiers

Primary DI / UDI-DI
00856312006236 FDA UDI
510(k) Number
K123172 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Disposable Irrigating Bipolar Forceps, 8", Micro Tips by Katalyst Surgical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.

Cleared under the same submission

K123172 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Katalyst Surgical, Llc

Sources (1)

  • FDA UDI c8567e4a-3407-4329-acb0-49c0f7722a40 34 fields · synced May 31, 2026