← Back to catalogue

Locking/Ratcheting Handle

FDA UDI

Class II (US FDA UDI)

by Orange Surgical Instruments, Llc

Identity

Trade Name
Locking/Ratcheting Handle FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
Locking/Ratcheting Handle FDA UDI
Model / Reference
OSC6000R FDA UDI
Description
Locking/Ratcheting Handle FDA UDI

Identifiers

Primary DI / UDI-DI
B354OSC6000R5 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic electrosurgical electrode, monopolar, single-use

Locking/Ratcheting Handle 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orange Surgical Instruments, Llc

Sources (1)

  • FDA UDI b46a5c95-c0e5-4b9f-9e01-ac9ef5286537 33 fields · synced Jun 8, 2026