Identity
- Trade Name
- SLS 9000 FDA UDI
- Generic Name
- Operating room light system FDA UDI
- Model / Reference
- 70Z500MA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815871020749 FDA UDI
- FDA Product Code
- FQP FDA UDI
- GMDN Term
- Operating room light system 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
No
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
No
FDA UDI
Category: Operating room light system
A comprehensive operating room light system designed for general illumination in the OR, featuring a combination of lamp and satellite lights mounted on independent rotating counterbalanced arms.
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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
- Avante
Sources (1)
- FDA UDI e435afaf-acd2-4be5-942d-d22ed7d52724 33 fields · synced Jul 25, 2026