Identity
- Trade Name
- UltraLite® FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- Integra® UltraLite® Pro replacement headband FDA UDI
- Model / Reference
- 001370LX FDA UDI
- Description
- Integra® UltraLite® Pro replacement headband FDA UDI
Identifiers
- Catalog Number
- 001370LX FDA UDI
- Primary DI / UDI-DI
- 10381780167990 FDA UDI
- 510(k) Number
- K864380 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Yes
FDA UDI
Category: General-purpose light source
UltraLite® 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
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- 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
Cleared under the same submission
K864380 also covers:
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
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
- Integra Lifesciences (ireland) Limited
Sources (1)
- FDA UDI 0e63abe9-ee8b-4f7b-8924-0fe14e7e74e7 36 fields · synced Jun 8, 2026