Identity
- Trade Name
- Millennium FDA UDI
- Generic Name
- Wire/ligature passer, reusable FDA UDI
- Device Name
- Swan Catheter Guide, 2mm, 25 1/4" OL FDA UDI
- Model / Reference
- 1-SWAN FDA UDI
- Description
- Swan Catheter Guide, 2mm, 25 1/4" OL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776394202 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Wire/ligature passer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wire/ligature passer, reusable
Millennium by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wire/ligature passer, reusable.
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI 8f4a0bfc-8956-482f-b990-fa73d6b9799e 34 fields · synced May 30, 2026