Identity
- Trade Name
- Eighteeth FDA UDI
- Generic Name
- Head-worn lamp FDA UDI
- Device Name
- Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment. FDA UDI
- Model / Reference
- Wireless Z+ FDA UDI
- Description
- Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment. FDA UDI
Identifiers
- Catalog Number
- 5080909 FDA UDI
- Primary DI / UDI-DI
- 06941877822248 FDA UDI
- FDA Product Code
- EBA FDA UDI
- GMDN Term
- Head-worn lamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4630 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
Yes
FDA UDI
Category: Head-worn lamp
Eighteeth by Changzhou Sifary Medical Technology Co., Ltd. — 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
- Changzhou Sifary Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 37c7e657-542a-4a05-a49d-df47e7f03c23 34 fields · synced May 30, 2026