Identity
- Trade Name
- Video Camera Insert FDA UDI
- Generic Name
- Operator eye protection laser filter FDA UDI
- Device Name
- Video Camera Insert/Filter For Rigid Endoscope FDA UDI
- Model / Reference
- 0010-0728 FDA UDI
- Description
- Video Camera Insert/Filter For Rigid Endoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00878953007656 FDA UDI
- FDA Product Code
- FEM FDA UDI
- GMDN Term
- Operator eye protection laser filter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operator eye protection laser filter
Video Camera Insert by American Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PUREPOINT — Alcon Laboratories, Inc. · Class II
- Fixed Eye Safety Filter — Lumenis Be, Inc. · Class II
- Automatic Eye Safety Filter — Lumenis Be, Inc. · Class II
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
- American Medical Systems, Inc.
Sources (1)
- FDA UDI 8960d4ed-5fd0-4d64-9817-d2e9ed2a3489 34 fields · synced May 30, 2026