Identity
- Trade Name
- Light cable with iris, for head-light FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- 10-110-00 (WITHOUT headband), with Storz adapter FDA UDI
- Model / Reference
- 10-110-03 FDA UDI
- Description
- 10-110-00 (WITHOUT headband), with Storz adapter FDA UDI
Identifiers
- Catalog Number
- 10-110-03 FDA UDI
- Primary DI / UDI-DI
- 04251823391257 FDA UDI
- FDA Product Code
- EQH FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4350 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
Yes
FDA UDI
Category: Operating room light
Light cable with iris, for head-light by Spiggle & Theis Medizintechnik GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI 7b80e670-be4e-4ed1-8691-ef6d64e597bb 35 fields · synced Jun 6, 2026