← Back to catalogue

Flood Phantom

FDA UDI

Class I (US FDA UDI)

by Biodex Medical Systems

Identity

Trade Name
Flood Phantom FDA UDI
Generic Name
Nuclear medicine phantom, flood source FDA UDI
Device Name
Flood Phantom, Rectangular, Fillable FDA UDI
Model / Reference
243-054 FDA UDI
Description
Flood Phantom, Rectangular, Fillable FDA UDI

Identifiers

Catalog Number
243-054 FDA UDI
Primary DI / UDI-DI
00718175000540 FDA UDI
FDA Product Code
IYQ FDA UDI
GMDN Term
Nuclear medicine phantom, flood source FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1380 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, flood source

Flood 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, flood source.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biodex Medical Systems

Sources (1)

  • FDA UDI d93f8bbc-ba82-4db6-94d3-4d8d5e66cf4e 34 fields · synced May 30, 2026