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Palindrome

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name
Palindrome FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
H Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating, Pre-Curved Shaft and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 33 cm FDA UDI
Model / Reference
8888133511 FDA UDI
Description
H Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating, Pre-Curved Shaft and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 33 cm FDA UDI

Identifiers

Catalog Number
8888133511 FDA UDI
Primary DI / UDI-DI
10884521056640 FDA UDI
510(k) Number
K112477 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

Yes

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 — 14.5 French FDA UDI
Length — 33 Centimeter FDA UDI

Palindrome by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112477 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mozarc Medical US LLC

Sources (1)

  • FDA UDI 2f809339-3fc6-4aa6-8c42-12a296f2e86a 38 fields · synced Jun 8, 2026