Identity
- Trade Name
- Camera Cover FDA UDI
- Generic Name
- Medical equipment handle cover, reusable FDA UDI
- Device Name
- Sterilizable Camera Cover with intensity control for Lumos Series, black FDA UDI
- Model / Reference
- B1-530-50-B FDA UDI
- Description
- Sterilizable Camera Cover with intensity control for Lumos Series, black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736124168 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Medical equipment handle cover, reusable
Camera Cover by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment handle cover, reusable.
- HarmonyAIR — STERIS CORPORATION · Class I
- HarmonyAIR — STERIS CORPORATION · Class I
- STERILIZABLE HANDLE TVCC FOR UNICA/U29 — RIMSA P. LONGONI SRL · Class II
- STERILIZABLE HANDLE TVCC PREDISPOSITION FOR UNICA/U29 — RIMSA P. LONGONI SRL · Class II
- STERILIZABLE HANDLE FOR UNICA/U29 — RIMSA P. LONGONI SRL · Class II
- 7D Surgical Light Handle — 7D Surgical ULC · Class II
- COVER, CARDIOSAVE RAIN — Datascope Corp. · Class II
- HarmonyAIR — STERIS CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Skytron, LLC
Sources (1)
- FDA UDI ae82799c-7ffd-405f-8abd-3d6a212ce72a 34 fields · synced May 30, 2026