Identity
- Trade Name
- Huestis Medical Flexi-Holder FDA UDI
- Generic Name
- X-ray film cassette holder FDA UDI
- Device Name
- Flexi-Holder 26" Short Arm, Huestis Part # FH303 FDA UDI
- Model / Reference
- FH303 FDA UDI
- Description
- Flexi-Holder 26" Short Arm, Huestis Part # FH303 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850077007071 FDA UDI
- 510(k) Number
- K792721 FDA UDI
- FDA Product Code
- IXA FDA UDI
- GMDN Term
- X-ray film cassette holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1850 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray film cassette holder
Huestis Medical Flexi-Holder by Huestis Machine Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K792721 also covers:
- Huestis Medical Flexi-Holder — HUESTIS MACHINE CORP.
- Huestis Medical Flexi-Holder — HUESTIS MACHINE CORP.
- Huestis Medical Flexi-Holder — HUESTIS MACHINE CORP.
- Huestis Medical Flexi-Holder — HUESTIS MACHINE CORP.
- Huestis Medical Flexi-Holder — HUESTIS MACHINE CORP.
- Huestis Medical Flexi-Holder — HUESTIS MACHINE 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
- Huestis Machine Corp.
Sources (1)
- FDA UDI 65163e9d-0b07-47a2-9438-84b0ff2250a5 34 fields · synced Jun 1, 2026