Reusable Non-Locking Comfort Handle

FDA UDI

Class II (US FDA UDI)

by Orange Surgical Instruments, Llc

Identity

Trade Name: Reusable Non-Locking Comfort Handle FDA UDI
Generic Name: Tissue extraction bag FDA UDI
Device Name: Reusable Non-Locking Comfort Handle FDA UDI
Model / Reference: SD388376 FDA UDI
Description: Reusable Non-Locking Comfort Handle FDA UDI

Identifiers

Catalog Number: SD388376 FDA UDI
Primary DI / UDI-DI: B354SD3883760 FDA UDI
FDA Product Code: GCJ FDA UDI
GEI FDA UDI
GMDN Term: Tissue extraction bag FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Peracetic Acid FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, single-use Tissue extraction bag

Reusable Non-Locking Comfort Handle by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue extraction bag.

Alexis® Contained Extraction System — APPLIED MEDICAL RESOURCES CORP. · Class II
SimplyStrong — Genicon · Class II
DR. POYNTER MC — APPLIED MEDICAL RESOURCES CORP. · Class II
DR.BRIZENDINE LAP CHOLECYSTECTOMY — APPLIED MEDICAL RESOURCES CORP. · Class I
GeniStrong — Genicon · Class II
TOTAL 5mm SOLUTION KIT 11 — APPLIED MEDICAL RESOURCES CORP. · Class II
PARTNERS LC KIT 006 — APPLIED MEDICAL RESOURCES CORP. · Class II
DR. FILLMORE LAP CHOLE KIT — APPLIED MEDICAL RESOURCES CORP. · Class II

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: Orange Surgical Instruments, Llc

Sources (1)

FDA UDI e149e141-64e1-498e-a813-0913e9664e92 34 fields · synced Jun 1, 2026