Identity
- Trade Name
- Palindrome FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- SI Chronic Catheter Sport Pack Symmetrical Tip, Silver Ion Sleeve and Tal VenaTrac Stylet FDA UDI
- Model / Reference
- 8888128458 FDA UDI
- Description
- SI Chronic Catheter Sport Pack Symmetrical Tip, Silver Ion Sleeve and Tal VenaTrac Stylet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521013032 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
- 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
- Length — 28 Centimeter FDA UDICatheter Gauge — 14.5 French FDA UDI
Category: Double-lumen haemodialysis catheter, implantable
Palindrome by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Double-lumen haemodialysis catheter, implantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc. · Class II
- HEMO-FLOW® — MEDICAL COMPONENTS INC · Class II
- DuraFlow™2 — Merit Medical Systems, Inc. · Class II
- HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc. · Class II
Cleared under the same submission
K112477 also covers:
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
- Palindrome — Mozarc Medical US LLC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mozarc Medical US LLC
Sources (1)
- FDA UDI c7322a42-3fa4-43de-8dff-db579e8df860 36 fields · synced Jun 8, 2026