Identity
- Trade Name
- Integra® Duo FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- Integra® Duo Duo 2 Bay Power Kit with Two Batteries, Charger, Power Supply, Charger Cord & Holster - US FDA UDI
- Model / Reference
- 90630US FDA UDI
- Description
- Integra® Duo Duo 2 Bay Power Kit with Two Batteries, Charger, Power Supply, Charger Cord & Holster - US FDA UDI
Identifiers
- Catalog Number
- 90630US FDA UDI
- Primary DI / UDI-DI
- 10381780490906 FDA UDI
- FDA Product Code
- FSR FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4335 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose light source
Integra® Duo by Integra Lifesciences (ireland) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose light source.
- Integra® — Integra LifeSciences Production Corporation · Class II
- Orascoptic - Endeavour TruColor Headlight System — METREX RESEARCH · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- NICO Myriad-LX — NICO Corporation · Class II
- Integra® — Integra LifeSciences Production Corporation · Class II
- Orascoptic - Endeavour TruColor Headlight System — METREX RESEARCH · Class I
- Orascoptic - Endeavour TruColor XL Headlight System — METREX RESEARCH · Class I
- Integra® — Integra LifeSciences Production Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences (ireland) Limited
Sources (1)
- FDA UDI 8dc100eb-6aa8-4a3a-b5cf-07b3845ee893 36 fields · synced May 30, 2026