Identity
- Trade Name
- Simulator Dot Reticle Set FDA UDI
- Generic Name
- Patient positioning patterned-light instrument FDA UDI
- Model / Reference
- 54-883 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365548830 FDA UDI
- FDA Product Code
- IWE FDA UDI
- GMDN Term
- Patient positioning patterned-light instrument FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5780 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
Category: Patient positioning patterned-light instrument
Simulator Dot Reticle Set by Aktina Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning patterned-light instrument.
- Cross-Hair Reticule, Radiation Opaque — Aktina Corp. · Class I
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- Cross-Hair Reticule, XRETIC — Aktina Corp. · 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
- Aktina Corp.
Sources (1)
- FDA UDI 2a5e5171-8ad7-417e-8683-c7bb8b33d968 32 fields · synced Jun 8, 2026