Question 1

What types of medical devices does SURJEX manufacture?

Accepted Answer

SURJEX manufactures a variety of reusable surgical instruments designed for general surgical and orthopaedic procedures. Their product range includes dressing and utility forceps, soft-tissue manipulation forceps, suturing needle holders, bone holding forceps, hand-held retractors, clamp manipulation forceps, orthopaedic rongeurs, and bone levers or elevators. These tools are specifically engineered to assist medical professionals with tissue handling, suturing, and bone manipulation tasks.

Question 2

Where is SURJEX based?

Accepted Answer

SURJEX is based in the United States. The company operates from this location and adheres to all applicable domestic regulatory requirements for the production and distribution of their reusable surgical instruments.

Question 3

How are the devices from SURJEX classified and where are they listed?

Accepted Answer

All devices manufactured by SURJEX are classified as Class I medical devices. These instruments are officially listed in the FDA’s Unique Device Identifier (UDI) database. This classification and registration reflect the regulatory status of their reusable surgical tools within the United States market.

Device	Model / Reference	Registries	Class	Status
Surjex	19-808	FDA UDI	Class I	Active
Surjex	WM1882018, WM1882118	FDA UDI	Class I	Active
Surjex	WM1882018	FDA UDI	Class I	Active
Surjex	WM1413S3	FDA UDI	Class I	Active
Surjex	WM3197470, WM3197455	FDA UDI	Class I	Active
Surjex	WM3197476	FDA UDI	Class I	Active
Surjex	1-136	FDA UDI	Class I	Active
Surjex	WM0415S3	FDA UDI	Class I	Active
Surjex	WM9873320 to WM9873333	FDA UDI	Class I	Active
Surjex	WM0318S3	FDA UDI	Class I	Active
Surjex	WM1415S3	FDA UDI	Class I	Active
Surjex	WM0315-C	FDA UDI	Class I	Active
Surjex	WM0418S3	FDA UDI	Class I	Active
Surjex	WM3240913	FDA UDI	Class I	Active
Surjex	8-15TC	FDA UDI	Class I	Active
Surjex	WM8535437	FDA UDI	Class I	Active
Surjex	WM0405S3	FDA UDI	Class I	Active
Surjex	19-850	FDA UDI	Class I	Active
Surjex	8-14TC	FDA UDI	Class I	Active
Surjex	WM3240916	FDA UDI	Class I	Active
Surjex	WM7861771-01	FDA UDI	Class I	Active
Surjex	13-138	FDA UDI	Class I	Active
Surjex	WM4612075, WM4612090, WM4612035	FDA UDI	Class I	Active
Surjex	WM3197440-WM3197441	FDA UDI	Class I	Active
Surjex	WM0415S3	FDA UDI	Class I	Active
Surjex	WM3197445	FDA UDI	Class I	Active
Surjex	7-24	FDA UDI	Class I	Active
Surjex	WM4642322	FDA UDI	Class I	Active
Surjex	WM3241113	FDA UDI	Class I	Active
Surjex	WM0413S3	FDA UDI	Class I	Active
Surjex	8-15TC	FDA UDI	Class I	Active

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