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
Baton 10mm Foam	CCBF1410	FDA UDI	Class II	Active
Curved Metzenbaum Scissor, 44cm, Disposable	OS445MCMSW	FDA UDI	Class II	Active
Maryland 30 Degree inner shaft	262B	FDA UDI	Class II	Unknown
Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm Shaft	CCLCS5	FDA UDI	Class II	Active
Needle Holder Left Curve	343L	FDA UDI	Class II	Unknown
Padded Grasper Tip	OSPG	FDA UDI	Class II	Active
Lap-Port Closure Device	OSLPCD	FDA UDI	Class II	Active
Blunt Nose inner shaft	266B	FDA UDI	Class II	Unknown
Nylon Extra Large Retrieval Pouch	OS811RP	FDA UDI	Class II	Active
Maryland, Large Head Inner Shaft 10mm	367	FDA UDI	Class II	Unknown
Fenestrated Atraumatic Forceps Inner Shaft	279	FDA UDI	Class II	Unknown
Straight Dissector Inner Shaft	261	FDA UDI	Class II	Unknown
Maryland 70 Degree inner shaft 43cm	C264B	FDA UDI	Class II	Active
Stainless Steel Cardiac 2 Finger Heart Retractor - Small	HAF2LGS	FDA UDI	Class II	Active
Fenestrated Atraumatic Forceps Inner Shaft 43cm	279B	FDA UDI	Class II	Unknown
Curved Metzenbaum Scissor, 33cm, Disposable	OS335MCMSW	FDA UDI	Class II	Active
Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7"	OSRP57W	FDA UDI	Class I	Unknown
Grasper Atraumatic, 34mm Blade, 44cm, Disposable	OS445G34	FDA UDI	Class II	Unknown
L Hook non-stick with cable	OSLHOOK445C	FDA UDI	Class II	Unknown
Fenestrated Atraumatic Forceps Inner Shaft	C279	FDA UDI	Class II	Active
Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm Shaft	CCLCS8	FDA UDI	Class II	Active
Needle Holder Straight	344S	FDA UDI	Class II	Active
Duck Bill Forceps Inner Shaft 43cm	C277B	FDA UDI	Class II	Active
Monopolar Metzenbaum Scissor, Mini Blade Tip, Disposable	OS3152	FDA UDI	Class II	Active
Fenestrated Atraumatic Forceps Inner Shaft	279	FDA UDI	Class II	Unknown
Retrieval Pouch (Multi Deploy) 12mm	OSRP12	FDA UDI	Class II	Active
Suture Closure II 15mm	OSSCII	FDA UDI	Class II	Active
Hook scissor inner shaft 44	258B	FDA UDI	Class II	Unknown
Maryland 45 Degree inner shaft 43cm	C263B	FDA UDI	Class II	Active
Debakey Grasper Inner Shaft 43cm	276B	FDA UDI	Class II	Unknown
Blunt Nose inner shaft	266B	FDA UDI	Class II	Unknown
Lens Cleaner Foam Sleeve for 5mm Shaft	CCS5	FDA UDI	Class II	Active
Lap-port Closure Device - Bariatric Kit	OSLPCDBK	FDA UDI	Class II	Active
Baton 10mm Foam	CCBF1410	FDA UDI	Class II	Active
Stomach Grasper Double Action Inner Shaft	C332	FDA UDI	Class II	Active
Curved Metzenbaum Scissor, 33cm, Disposable White Handle	OS335MCMSW	FDA UDI	Class II	Active
Alligator Padded Grasper	OSAPG	FDA UDI	Class II	Active
Posts	OSMP	FDA UDI	Class II	Active
Reusable Handle with Ratchet	OSRMHRB	FDA UDI	Class II	Active
Babcock Forceps Inner Shaft	C275	FDA UDI	Class II	Active
L Hook J Hook Spatula Suction Irrigation	OSLHOOKSI	FDA UDI	Class II	Active
3 ring suture kit bariatric with 5mm and 10mm swab	OS3CDBKS	FDA UDI	Class II	Active
Wave Grasper Inner shaft 43cm	C274B	FDA UDI	Class II	Active
Lap-port closure device guides 5mm and 10/12 mm	OSLPCDG510/12	FDA UDI	Class II	Active
Alligator Grasper Inner Shaft	C273	FDA UDI	Class II	Active
Reusable Handle - Tips 42mm	OS4	FDA UDI	Class II	Active
Stainless Steel Cardiac 2 Finger Heart Retractor - Large	HAF2SHS	FDA UDI	Class II	Active
Outer shaft	5OS	FDA UDI	Class II	Unknown
L Hook nonstick for ESU Pencil	OSLHOOK335P	FDA UDI	Class II	Unknown
Hook Scissor Inner Shaft	C258	FDA UDI	Class II	Active

ORANGE SURGICAL INSTRUMENTS, LLC

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