Woven Filiform Spiral Tip

FDA UDI

Class I (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: Woven Filiform Spiral Tip FDA UDI
Generic Name: Urethral dilator, reusable FDA UDI
Device Name: Woven Filiform Spiral Tip FDA UDI
Model / Reference: 022104 FDA UDI
Description: Woven Filiform Spiral Tip FDA UDI

Identifiers

Catalog Number: 022104 FDA UDI
Primary DI / UDI-DI: 00801741073168 FDA UDI
FDA Product Code: FBW FDA UDI
GMDN Term: Urethral dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 12.5 Inch FDA UDI
Catheter Gauge — 4 French FDA UDI

Category: Urethral dilator, reusable

The Woven Filiform Spiral Tip is a reusable urethral dilator used to treat strictures of the urethra, facilitate catheter placement, and extract stones (renal calculi). It is available in various sizes and may include a mechanical expanding mechanism. The device has been published for commercial distribution and is considered a primary medical device. For more information on its use, safety, and compliance, please refer to our detailed documentation.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: C. R. Bard, Inc.

Sources (1)

FDA UDI 4c7437e7-e5e9-44be-be21-d2820dcdd923 36 fields · synced Jul 30, 2026