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Reusable Monopolar Handle-Tips 42 cm

FDA UDI

Class II (US FDA UDI)

by Orange Surgical Instruments, Llc

Identity

Trade Name
Reusable Monopolar Handle-Tips 42 cm FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
Reusable Monopolar Handle-Tips 42 cm FDA UDI
Model / Reference
8000015650 FDA UDI
Description
Reusable Monopolar Handle-Tips 42 cm FDA UDI

Identifiers

Primary DI / UDI-DI
B35480000156501 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Peracetic Acid FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusableEndoscopic electrosurgical electrode, monopolar, single-use

Reusable Monopolar Handle-Tips 42 cm by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orange Surgical Instruments, Llc

Sources (1)

  • FDA UDI 149fde88-87e9-4a8b-9cac-1b7570473e0a 33 fields · synced May 31, 2026