Probe, Rectal, Non-Powered

Which Manufacturers in China Make This?

The one Chinese manufacturer registered for this device type is based in Shanghai.

Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer

What Is FDA Product Code EXX?

Probe, Rectal, Non-Powered is FDA product code EXX, Class 1, 21 CFR 876.4730.

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.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2009. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Probe, Rectal, Non-Powered

MSI Precision Specialty Instruments

Pratt Malleable Rectal Probe, Overall Length 10" (254mm)

Probe, Rectal, Non-Powered

Medrad® PRO-Tekt Endorectal Balloon

MEDRAD PRO-TEKT Endorectal Balloon (PRO-TEKT Endorectal Balloon, PROT50) (60729377)

Probe, Rectal, Non-Powered

GreenEgg

DEVICE DESCRIPTION The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The…

Probe, Rectal, Non-Powered

Ambler Surgical

Larry rectal probe/groove director, 6''

Probe, Rectal, Non-Powered

Gimmi

Probe Pointed Length 140 MM

Probe, Rectal, Non-Powered

V. Mueller

V. Mueller STEWART CRYPT HOOK LONG HOOK HOOK LENGTH 1-1/8 inches 2.9CM OVERALL LENGTH 9 inches 22.9CM

Probe, Rectal, Non-Powered

Millennium

Stewart Crypt Hook short hook

Probe, Rectal, Non-Powered

Novo Surgical Inc.

pratt fistula probe, crypt hooks, 8 1/4" (21.0 cm), short hook

Probe, Rectal, Non-Powered

BR Surgical, LLC

PRATT Rectal Probe, with sterling shaft, 8"

Probe, Rectal, Non-Powered

Aesculap

KIRSCHNER Guiding Probe, 10" (255 mm), width: 4,50 mm

Probe, Rectal, Non-Powered

Marina Medical

Supracervical Probe w/Solid Ø5cm Concave Tip, Green Handle (NON-RETURNABLE)

Probe, Rectal, Non-Powered

Medicon

Lockhart Mummery probe 16cm fig 2

Probe, Rectal, Non-Powered

Novo Surgical

zenith pratt fistula probe, crypt hooks, 8-1/4" (21.0 cm), narrow hook

Probe, Rectal, Non-Powered

Integra® Miltex®

Integra® Miltex® Buie Fistula Probe, 5-3/8" Working Length, 1.5mm Tip, Light, Silver

Probe, Rectal, Non-Powered

Integra® Jarit®

Integra® Jarit® Buie Fistula Probe, 5-3/8" Working Length, 1.5mm Tip, Light, Silver

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer