Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- Integra® LED Headlight with Batteris & AC/DC Power Supply - US FDA UDI
- Model / Reference
- 90520US FDA UDI
- Description
- Integra® LED Headlight with Batteris & AC/DC Power Supply - US FDA UDI
Identifiers
- Catalog Number
- 90520US FDA UDI
- Primary DI / UDI-DI
- 10381780168607 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
No
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® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Production Corporation
Sources (1)
- FDA UDI 08a5733a-16fc-41b3-84e0-32c81e9c54ff 36 fields · synced Jun 9, 2026