Identity
- Trade Name
- Accu-Beam FDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- Oculocam smartphone kit (eyepiece and external mount). FDA UDI
- Model / Reference
- 8100SP-Kit FDA UDI
- Description
- Oculocam smartphone kit (eyepiece and external mount). FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1778100SPKIT0 FDA UDI
- FDA Product Code
- KQM FDA UDI
- GMDN Term
- Surgical camera holder 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical camera holder
Accu-Beam by Transamerican Technologies International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical camera holder.
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- TEE Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class I
- Cord SET USA/CAN-C7 — Aktormed GmbH · Class II
- TEE Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class I
- Maestro System — Moon Surgical, 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
- Transamerican Technologies International
Sources (1)
- FDA UDI 942c7173-85d3-4b84-a641-ae7392893f62 33 fields · synced Jun 9, 2026