Question 1

What does Orange Surgical Instruments, LLC make?

Accepted Answer

Orange Surgical Instruments, LLC manufactures endoscopic electrosurgical electrodes and handpieces, both monopolar and available as single-use or reusable designs. They also produce insufflation gas conditioning tubing sets, laparoscopic wound closure thread, and tissue extraction bags, including specific devices such as Mixter and Maryland inner shafts, lens cleaners, blunt nose short inner shafts, cardiac retractors, suture passers, smoke pencils, retrieval pouches, reusable ratchet handles, hook scissor inner shafts, and outer shafts for reusable instruments.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. Orange Surgical Instruments, LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Orange Surgical Instruments, LLC based?

Accepted Answer

Orange Surgical Instruments, LLC is based in the United States, as stated in the device data under the COUNTRY field, which specifies US.

Question 3

Which regulatory registries list the devices of Orange Surgical Instruments, LLC?

Accepted Answer

The devices of Orange Surgical Instruments, LLC are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field of the device data.

Question 4

How are the devices of Orange Surgical Instruments, LLC classified?

Accepted Answer

The devices of Orange Surgical Instruments, LLC are classified as Class I and Class II medical devices, as specified in the DEVICE CLASSES field of the device data.

Device	Model / Reference	Registries	Class	Status
L-Hook Blunt	C350	FDA UDI	Class II	Active
Duck Bill Forceps Inner Shaft 10mm	101	FDA UDI	Class II	Unknown
Dorsey Grasper Inner Shaft	337	FDA UDI	Class II	Unknown
Stainless Steel Cardiac 3 Finger Heart Retractor - Large	OSCFRLG3	FDA UDI	Class II	Active
Grasping Forcep Inner Shaft	548	FDA UDI	Class II	Unknown
Needle Holder Self Righting Short	C351	FDA UDI	Class II	Active
Mesentery Forcep Inner Shaft	C335	FDA UDI	Class II	Active
Fundus Grasping Forcep 43cm	C290B	FDA UDI	Class II	Active
Reusable Handle with Ratchet	OSRMHRB	FDA UDI	Class II	Active
Curved Stainless Steel Arm Guard	OSCSAG	FDA UDI	Class II	Active
Maryland 0 Degree inner shaft 43cm	C261B	FDA UDI	Class II	Active
Long Fenestrated, (1 Set: handle, inner shaft, outer shaft)	OS5339	FDA UDI	Class II	Unknown
Suture Closure II 10mm	OSSCII	FDA UDI	Class II	Active
Maryland 30 Degree inner shaft 43cm	C262B	FDA UDI	Class II	Active
Atraumatic Fenestrated Grasper Tip Long	OSAFGL	FDA UDI	Class II	Active
Rat Tooth Forceps 3+2 teeth double action Inner Shaft	271	FDA UDI	Class II	Unknown
Blunt Nose inner shaft 43cm	C266B	FDA UDI	Class II	Active
Grasper Traumatic, Shaft insert, 44 cm, Disposable	OS445MGTI0	FDA UDI	Class II	Unknown
8mm x 16mm Foam Sleeves	CCS816	FDA UDI	Class II	Active
Reusable Ratchet Handle - Tips 42cm Each Bariatric	OS5B	FDA UDI	Class II	Active
3 Ring Suture Passer	OS3CD	FDA UDI	Class II	Active
Maryland Dissector fully disposable Bariatric 5mm x 44cm	OSMDDB	FDA UDI	Class II	Active
Stainless Steel Cardiac 3 Finger Heart Retractor	HAF3SHS	FDA UDI	Class II	Active
Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm Shaft	CCLCS8	FDA UDI	Class II	Active

ORANGE SURGICAL INSTRUMENTS, LLC

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