Sound, Urethral, Metal or Plastic

Which Manufacturers in China Make This?

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

Xinhua Surgical Instrument Co., Ltd. Shandong

How Is FBX Classified?

Sound, Urethral, Metal Or Plastic is FDA product code FBX, Class 1, 21 CFR 876.5520.

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 Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Sound, Urethral, Metal Or Plastic

VAN Buren Sound SET

Catalogue number 516-319, listed by Sontec Instruments, Inc., United States, under Sound, Urethral, Metal Or Plastic. 1 manufacturer in China is registered for this product code.

Sound, Urethral, Metal Or Plastic

Dila-Cath Nelaton 40cm CH18

Urinary catheter for intermittent dilatation

Sound, Urethral, Metal Or Plastic

VAN Buren Urethral Sound

3 catalogue numbers from 516-320, listed by Sontec Instruments, Inc., United States, under Sound, Urethral, Metal Or Plastic. 1 manufacturer in China is registered for this product code.

Sound, Urethral, Metal Or Plastic

Dila-Cath Nelaton 40cm CH16

Urinary catheter for intermittent dilatation

Sound, Urethral, Metal Or Plastic

Dilator

Bougies, VAN Buren, NO. 18

Sound, Urethral, Metal Or Plastic

Symmetry Dittel

Ultra Instruments® Sound, Dittel Surgical Urethral, Curved, 6 Fr

Sound, Urethral, Metal Or Plastic

Prostagrip™

Prostagrip™ Device

Sound, Urethral, Metal Or Plastic

Bard® Goodwin Sounds

Bard Goodwin Urethral Sound Complete Set 12 thru 30 Fr., Non-Sterile

Sound, Urethral, Metal Or Plastic

MSI Precision Specialty Instruments

McCrea Infant Urethral Sound, Curved, Plain Tip, 12Fr, Overall Length 7" (178mm)

Sound, Urethral, Metal Or Plastic

Bard® McCrea Model Female Urethral Sound

Bard Metal (McCrea Model) Female Sound Stainless Steel 32 Fr.

Sound, Urethral, Metal Or Plastic

Symmetry Mccrea

Symmetry® Sound, Mccrea Infant Urethral, 12 Fr, 7 in, 177 mm

Sound, Urethral, Metal Or Plastic

Kmedic

13 catalogue numbers from IPN015526, listed by Teleflex Medical LLC, United States, under Sound, Urethral, Metal Or Plastic. 1 manufacturer in China is registered for this product code.

Sound, Urethral, Metal Or Plastic

Symmetry Van Buren

Symmetry® Kit/Set, Van Buren Urethral Sound, 8-30 Fr, Curved, 10 3/4 in, (Set of 12)

Sound, Urethral, Metal Or Plastic

Trinity Sterile, Inc.

Sims Uterine Sound 12 1/2| PLN

Sound, Urethral, Metal Or Plastic

Millennium

Van Buren Urethral Sound 38fr

Sound, Urethral, Metal Or Plastic

Bard® Goodwin Sound

Bard Goodwin Sound Open Tip 12 Fr.

Sound, Urethral, Metal Or Plastic

HNM Medical

VAN Buren Urethral Sound SET, SET OF 12, 8FR TO 30FR CVD

Sound, Urethral, Metal Or Plastic

Bard® Metal Sound, Adult Male Length With Prostatic Curve

Bard Metal Sound Adult Male Length with Prostatic Curve, Stainless Steel 22 Fr.

Sound, Urethral, Metal Or Plastic

Marina Medical

Van Buren Urethral Sound Set of 12, 8Fr (2.6mm) - 30Fr (10.0mm), 28cm (11")

Sound, Urethral, Metal Or Plastic

Bard® LeFort Metal Sound

Bard LeFort Metal Sound, Threaded Tip, Stainless Steel 22 Fr.

Sound, Urethral, Metal Or Plastic

Bard® Walther Dilator-Catheter

Bard Walther Female Meatal Dilator-Catheter Stainless Steel 34 Fr.

Sound, Urethral, Metal Or Plastic

Pilling

14 catalogue numbers from IPN004636, listed by Teleflex Medical LLC, United States, under Sound, Urethral, Metal Or Plastic. 1 manufacturer in China is registered for this product code.

Sound, Urethral, Metal Or Plastic

Novo Surgical

lefort urethral sound, w/ standard 1-56 thread for filiform (not included), 11" (28.0 cm), 20 fr.

Sound, Urethral, Metal Or Plastic

BR Surgical, LLC

VanBUREN Urethral Sound Complete Set, 15 sounds (even sizes, Ø 8-36FR.)

Sound, Urethral, Metal Or Plastic

Medicon

Dittel urethral sound 20 Fr cvd 33.5cm

Sound, Urethral, Metal Or Plastic

Symmetry Surgical®

Symmetry® Sound, Walther Urethral, 18 Fr, 11 in

Sound, Urethral, Metal Or Plastic

Novo Surgical Inc.

van buren urethral sound, curved, 11" (27.9 cm), set of 6, 14 fr. to 24 fr., in khaki roll

Sound, Urethral, Metal Or Plastic

Greenwald Surgical Company, Inc.

Walther sound, curved, 1-34" nominal bend height. Features proximal taper to relax the penile meatus. Mirror finish, stainless steel, precision machined.

Sound, Urethral, Metal Or Plastic

V. Mueller

V. Mueller LEFORT URETHRAL SOUND 8FR, THREADED 1/56 inches FOR STD FILIFORM NOT INCLUDED OVERALL LENGTH 11 inches 28CM

Sound, Urethral, Metal Or Plastic

Integra® Jarit®

Integra® Jarit® Walther Female Dilator-Catheter, 5-3/4", 34 French

Sound, Urethral, Metal Or Plastic

Aesculap

VAN BUREN Urethral Catheter, 10 5/8" (270 mm), 34FR

Sound, Urethral, Metal Or Plastic

Hayden Medical

Walther Urethral Sounds 11" (27.9cm), (Set of 11), tapered shaft downward towards handle, 16Fr. (5.3mm) thru 36Fr. (11.9mm)

Sound, Urethral, Metal Or Plastic

Integra® Miltex®

Integra® Miltex® Van Buren Urethral Sounds, 10-3/4", Set Of 12, 8 Fr. Thru 30 Fr., Khaki Roll

Sound, Urethral, Metal Or Plastic

Sklar®

Censitrac Ready Simpson Sound W/Grad CM 12.5"

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