Drape, Microscope, Ophthalmic

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu.

Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. Jiangsu
Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu

How Is HMW Classified?

Drape, Microscope, Ophthalmic is FDA product code HMW, Class 2, 21 CFR 878.4370.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Drape, Microscope, Ophthalmic

Vashe Sterile Sleeve

The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over…

Drape, Microscope, Ophthalmic

Exact Medical Manufacturing, Inc.

Microscope Drape, Leica 137x381cm – 54” x 150”

Drape, Microscope, Ophthalmic

Cover, with elastic tip

Drape, Microscope, Ophthalmic

SpandaGrip

SpandaGrip Tubular Elastic Support Bandage - Size (L) 13 IN x11 Yds - Natural

Drape, Microscope, Ophthalmic

Adler Instrument Company

Rubin Osteotome, w/finger grip, TW 10mm(3/8") cutting edge 8mm OL 160mm (6-1/4")

Drape, Microscope, Ophthalmic

2-Pack Asepsis Visulux

Catalogue number 305810-9009-000, listed by Carl Zeiss Meditec Inc, United States, under Drape, Microscope, Ophthalmic. 2 manufacturers in China are registered for this product code.

Drape, Microscope, Ophthalmic

Sterilizable Metal Sleeve

Catalogue number 000000-0140-600, listed by Carl Zeiss Meditec Inc, United States, under Drape, Microscope, Ophthalmic. 2 manufacturers in China are registered for this product code.

Drape, Microscope, Ophthalmic

Optics ONE

Leica/Wild Microscope Drape w/angled lens 54 x 120 - with 4 oculars ..Uncoated

Drape, Microscope, Ophthalmic

V. Mueller

V. Mueller ENDOLAP X-RAY CASSETTE DRAPE 24X24IN

Drape, Microscope, Ophthalmic

Who Makes This Device Type in China?

How Is HMW Classified?

What Does It Take to Sell It in the United States?

Where China Actually Supplies