Identity
- Trade Name
- Millennium FDA UDI
- Generic Name
- General-purpose endoscopic needle, reusable FDA UDI
- Device Name
- Irrigating Puncture needle FDA UDI
- Model / Reference
- LI-490 FDA UDI
- Description
- Irrigating Puncture needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776083809 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- General-purpose endoscopic needle, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose endoscopic needle, reusable
Millennium by AVALIGN TECHNOLOGIES, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose endoscopic needle, reusable.
- Integra® MicroFrance® — Integra Microfrance · Class II
- MicroFrance® — Integra Microfrance · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
- Integra® MicroFrance® — Integra Microfrance · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
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 |
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Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI c70ec13f-5c13-4f63-adc1-639798ae60c8 34 fields · synced May 30, 2026