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Deflux®

FDA UDI

Class III (US FDA UDI)

by Salix Pharmaceuticals, Ltd.

Identity

Trade Name
Deflux® FDA UDI
Generic Name
Urinary tract reconstructive material, microbe-derived FDA UDI
Device Name
Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV. FDA UDI
Model / Reference
1092203 FDA UDI
Description
Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV. FDA UDI

Identifiers

Primary DI / UDI-DI
00365649922039 FDA UDI
FDA Product Code
LNM FDA UDI
GMDN Term
Urinary tract reconstructive material, microbe-derived FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Urinary tract reconstructive material, microbe-derived

Deflux® by Salix Pharmaceuticals, Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urinary tract reconstructive material, microbe-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Salix Pharmaceuticals, Ltd.

Sources (1)

  • FDA UDI 9ed694b5-66f3-4c21-ab35-02ab802f841c 34 fields · synced Jun 8, 2026