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Symetrex® Lthd Catheter

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
SYMETREX® LTHD CATHETER FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/STYLETS (CUFF 23CM FROM TIP ) FDA UDI
Model / Reference
MSPS023 FDA UDI
Description
15.5F X 23CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/STYLETS (CUFF 23CM FROM TIP ) FDA UDI

Identifiers

Catalog Number
MSPS023 FDA UDI
Primary DI / UDI-DI
00884908157055 FDA UDI
510(k) Number
K202176 FDA UDI
FDA Product Code
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
Not 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

Yes

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

Symetrex® Lthd Catheter by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K202176 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI 7f90b083-9245-4348-ac77-127ebdaf1e54 37 fields · synced Jun 1, 2026