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Sterilizable Handle for DoVera DE12 Examination Light Series
FDA UDIClass II (US FDA UDI)
by Skytron, LLC
Identity
- Trade Name
- Sterilizable Handle for DoVera DE12 Examination Light Series FDA UDI
- Generic Name
- Medical equipment handle cover, reusable FDA UDI
- Device Name
- DE12 Sterilizable Handle FDA UDI
- Model / Reference
- Z180045 FDA UDI
- Description
- DE12 Sterilizable Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736123536 FDA UDI
- FDA Product Code
- FTA FDA UDI
- GMDN Term
- Medical equipment handle cover, reusable 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Medical equipment handle cover, reusable
Sterilizable Handle for DoVera DE12 Examination Light Series by Skytron, LLC — 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
- Skytron, LLC
Sources (1)
- FDA UDI af4f11db-c84e-4023-bf72-47c99393f569 34 fields · synced May 30, 2026