Identity
- Trade Name
- Rando® FDA UDI
- Generic Name
- General-purpose diagnostic x-ray phantom, anthropomorphic FDA UDI
- Device Name
- Knee 90° flexion, right FDA UDI
- Model / Reference
- XA245R FDA UDI
- Description
- Knee 90° flexion, right FDA UDI
Identifiers
- Catalog Number
- XA245R FDA UDI
- Primary DI / UDI-DI
- 00812266030987 FDA UDI
- FDA Product Code
- IXG FDA UDI
- GMDN Term
- General-purpose diagnostic x-ray phantom, anthropomorphic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1950 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: General-purpose diagnostic x-ray phantom, anthropomorphic
Rando® by Providus Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose diagnostic x-ray phantom, anthropomorphic.
- Rando® — Providus Holdings, Inc. · Class I
- Rando® — Providus Holdings, Inc. · Class I
- Rando® — Providus Holdings, Inc. · Class I
- Rando® — Providus Holdings, Inc. · Class I
- Rando® — Providus Holdings, Inc. · Class I
- Rando® — Providus Holdings, Inc. · Class I
- Rando® — Providus Holdings, 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
- Providus Holdings, Inc.
Sources (1)
- FDA UDI c0eb8be4-d925-4eaa-9547-d2c5e65c65b2 34 fields · synced May 30, 2026