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
Tebbetts Type Septal Elevator, 4mm, Double Ended	SD9394301	FDA UDI	Class II	Unknown
8mm Plug x 3M Cable Disposable	OSMCD8MMX3M	FDA UDI	Class II	Active
Fundus Grasper Inner Shaft	C274	FDA UDI	Class II	Active
Tenaculum Tip	C278	FDA UDI	Class II	Active
Claws Forceps Inner Shaft	C382	FDA UDI	Class II	Active
Mesentary Forcep Inner Shaft	335	FDA UDI	Class II	Unknown
Maryland 45 Degree inner shaft 43cm	C263B	FDA UDI	Class II	Active
Alligator Grasper Inner Shaft	273	FDA UDI	Class II	Unknown
Reusable Guides 5mm-10/12mm Set	OSLPCDGR	FDA UDI	Class II	Active
Suture Closure II 10mm	OSSCII	FDA UDI	Class II	Active
Reusable Monopolar Handle-Tips 34cm	8000015649	FDA UDI	Class II	Active
Biopsy Punch Inner Shaft	115	FDA UDI	Class II	Unknown
Reusable Ratchet Handle - tips 34cm each	OS3R	FDA UDI	Class II	Active
Babcock inner shaft 43cm	C275B	FDA UDI	Class II	Active
Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm Shaft	CCLCS5	FDA UDI	Class II	Active
Lap port closure kit bariatric with 5mm and 10mm swab	OSLPCDBKS	FDA UDI	Class II	Active
Grasper Traumatic 33cm Disposable	OS335MGT	FDA UDI	Class II	Unknown
Stainless Steel Cardiac 3 Finger Heart Retractor - Small	OSCFRS3	FDA UDI	Class II	Active
Retrieval Pouch-Rip Stop W/Pull Strap 5" x 7"	OSRP57W	FDA UDI	Class II	Active
Fenestrated Long Inner Shaft	C339	FDA UDI	Class II	Active
Stainless Steel Cardiac 2 Finger Heart Retractor - Large	OSCFRLG2	FDA UDI	Class II	Active
Smoke Pencil	OSSP	FDA UDI	Class II	Active
3 Ring Suture Passer - 16 cm	OS3CD	FDA UDI	Class II	Active
Rat Tooth Forceps 3+2 teeth double action Inner Shaft	C271	FDA UDI	Class II	Active
Fenestrated Long Inner Shaft 43cm	C339B	FDA UDI	Class II	Active
Needle Holder Right Curve	343R	FDA UDI	Class II	Unknown
Babcock Inner Shaft 44	275B	FDA UDI	Class II	Unknown
Joysticks for head lamps	OSJS	FDA UDI	Class II	Active
Monopolar Metzenbaum scissor, Mini blade tip, Disposable	8000015653	FDA UDI	Class II	Active
Grasper Atraumatic, 34mm Blade w/Ratchet, 44cm, Disposable	OS445G34R	FDA UDI	Class II	Unknown
30 degree Maryland, (1 Set: handle, inner shaft, outer shaft) reusable	OS5262	FDA UDI	Class II	Unknown
J Hook non-stick without cable	OSJHook445	FDA UDI	Class II	Unknown
Duck Bill Forceps Inner Shaft	C277	FDA UDI	Class II	Active
Spatula non-stick without cable	OSSPAT445	FDA UDI	Class II	Unknown
Debakey Grasper Inner Shaft 43cm	C276B	FDA UDI	Class II	Active
Fenestrated Grasper Small Inner Shaft	281	FDA UDI	Class II	Unknown
Handle for 10mm	444	FDA UDI	Class II	Unknown
Curved Metzenbaum Scissor, 44cm, Disposable White Handle	OS445MCMSW	FDA UDI	Class II	Active
Hook Scissor, (1 Set: handle, inner shaft, outer shaft) reusable	OS5258	FDA UDI	Class II	Unknown
Monopolar Metzenbaum Scissor, Mini Blade Tip, Disposable	OS3152	FDA UDI	Class II	Active
Hunter Grasper Tip	OSHG	FDA UDI	Class II	Active
Fenestrated Grasper Inner Shaft 44cm	281B	FDA UDI	Class II	Unknown
Mixter Inner Shaft	265	FDA UDI	Class II	Unknown
L-Hook Blunt	C349	FDA UDI	Class II	Active
Fenestrated Grasper Small Inner Shaft	C281	FDA UDI	Class II	Active
Needle Holder Straight 33cm	OS349	FDA UDI	Class II	Active
Lens Cleaner foam Sleeve for 8mm Shaft	CCS8	FDA UDI	Class II	Active
Duck Bill Forceps Inner Shaft 43cm	277B	FDA UDI	Class II	Unknown
Clinch Grapser Inner Shaft	280	FDA UDI	Class II	Unknown
Tube Holder	OSCVORTH	FDA UDI	Class II	Active

ORANGE SURGICAL INSTRUMENTS, LLC

What ORANGE SURGICAL INSTRUMENTS, LLC makes

Frequently asked questions

Information

Catalogue (1674)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities