Identity
- Trade Name
- Bar Phantom FDA UDI
- Generic Name
- Nuclear medicine phantom, test object FDA UDI
- Device Name
- Bar Phantom, Cardiac, High Resolution FDA UDI
- Model / Reference
- 243-955 FDA UDI
- Description
- Bar Phantom, Cardiac, High Resolution FDA UDI
Identifiers
- Catalog Number
- 243-955 FDA UDI
- Primary DI / UDI-DI
- 00718175009550 FDA UDI
- FDA Product Code
- JAR FDA UDI
- GMDN Term
- Nuclear medicine phantom, test object FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1420 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
Yes
FDA UDI
Category: Nuclear medicine phantom, test object
Bar Phantom by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nuclear medicine phantom, test object.
- ASSEMBLY MR PET QC PHANTOM — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- ASM SRC LS-LA DET SET UP ROD — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- ASM SRC CS-20-1 UNIFORM PHANTOM — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- ASM LINE SOURCE MR-PET — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- ASM, CS-7 QC PHANTOM — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- SRC PHANTOM CS 20-2 GE68 2 MCI PLYU — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- ASM LINE SOURCE MR-PET — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class I
- SRC PHANTOM CS 20-2 GE68 2 MCI PLYU — SIEMENS MEDICAL SOLUTIONS USA, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biodex Medical Systems
Sources (1)
- FDA UDI a20e269e-85e4-49a4-b166-42295f3b22c2 34 fields · synced May 31, 2026