Identity
- Trade Name
- PROCAM PACK FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- CAMERA WITH INTEGRATE SCREEN AND LIGHT SOURCE FDA UDI
- Model / Reference
- RX1 FDA UDI
- Description
- CAMERA WITH INTEGRATE SCREEN AND LIGHT SOURCE FDA UDI
Identifiers
- Catalog Number
- AIO100B FDA UDI
- Primary DI / UDI-DI
- B366AIO100BRX1 FDA UDI
- FDA Product Code
- FWD FDA UDI
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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: Surgical video camera
Procam Pack by Ecleris — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical video camera.
- Accu-Beam — Transamerican Technologies International · Class I
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- FireCam HD Intraoral Camera — DIGIRAY Corp. · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Disposable cover_60x200_wide — GOOD DOCTORS CO., LTD. · Class I
- Dr's Cam_touch — GOOD DOCTORS CO., LTD. · Class I
- In-Light Camera — STRYKER Communications, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ecleris
Sources (1)
- FDA UDI fd118414-2ad9-4b10-a0b6-27a9415ca635 36 fields · synced May 31, 2026