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Schon

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name
Schon FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
14F x 24cm Schon XL Double Lumen (Short Term) FDA UDI
Model / Reference
10802703 FDA UDI
Description
14F x 24cm Schon XL Double Lumen (Short Term) FDA UDI

Identifiers

Primary DI / UDI-DI
H787108027030 FDA UDI
FDA Product Code
MPB FDA UDI
MSD FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, implantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5540 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

Dimensions & Sizes

Size
Catheter Gauge — 14 French FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Length — 24 Centimeter FDA UDI
Outer Diameter — 4.62 Millimeter FDA UDI

Category: Double-lumen haemodialysis catheter, implantable

Schon by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc

Sources (1)

  • FDA UDI d17d7fd2-fbb2-455c-85b1-a15aaba4f88d 36 fields · synced Oct 7, 2026