Identity
- Trade Name
- Film Holder FDA UDI
- Generic Name
- X-ray film cassette holder FDA UDI
- Model / Reference
- 50-375 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365503750 FDA UDI
- 510(k) Number
- K161984 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- X-ray film cassette holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray film cassette holder
Film Holder by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161984 also covers:
- Bar Code Reader Kit — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 10mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 11mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 12mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 13mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 15mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 16mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 17mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 18mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 20mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 22mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 23mm — Aktina Corp.
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 |
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Manufacturer
- Manufacturer
- Aktina Corp.
Sources (1)
- FDA UDI c3124e99-d6f1-4313-bcd9-263a1444a179 33 fields · synced May 31, 2026