Identity
- Trade Name
- Millennium FDA UDI
- Generic Name
- Upper-limb traction wrap/trap, reusable FDA UDI
- Device Name
- Lead Hand, Child FDA UDI
- Model / Reference
- 0-49092 FDA UDI
- Description
- Lead Hand, Child FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776361525 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Upper-limb traction wrap/trap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
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: Upper-limb traction wrap/trap, reusable
Millennium by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Upper-limb traction wrap/trap, reusable.
- ISI — INSTRUMENT SPECIALISTS, INC. · Class I
- ISI — INSTRUMENT SPECIALISTS, INC. · Class I
- ISI — INSTRUMENT SPECIALISTS, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
- ISI — INSTRUMENT SPECIALISTS, INC. · Class I
- TRAPS, FINGER, DOUBLE, 5/PK — AliMed, LLC · Class I
- ISI — INSTRUMENT SPECIALISTS, INC. · Class I
- INFLATABLE CUFF/STRAP ASSEMBLY — Mizuho Orthopedic Systems, Inc. · 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 d04b9022-8de5-4b74-8801-f8b7d658cd31 34 fields · synced Jun 8, 2026