Ultraxx

FDA UDI

Class U (US FDA UDI)

by Cook Incorporated

Identity

Trade Name: Ultraxx FDA UDI
Generic Name: Nephrostomy catheter FDA UDI
Device Name: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe FDA UDI
Model / Reference: G46037 FDA UDI
Description: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe FDA UDI

Identifiers

Catalog Number: UNBS-6-15-CS FDA UDI
Primary DI / UDI-DI: 00827002460379 FDA UDI
FDA Product Code: LJE FDA UDI
GMDN Term: Nephrostomy catheter FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nephrostomy catheter

Ultraxx by Cook Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nephrostomy catheter.

Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
Flexima™ — Boston Scientific · Class I
Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
Kolibri — Coloplast A/S · U
Total Abscession — ANGIODYNAMICS, INC · Class I
Percuflex™ — Boston Scientific · Class II
EZDilate — Gyrus Acmi, Inc. · Class II
Flexima™ — Boston Scientific · Class II

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 U	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cook Incorporated

Sources (1)

FDA UDI 9e353916-dcac-4162-9b48-6dd3ca91d9a0 36 fields · synced Jun 8, 2026