Sun Nuclear MultiPHAN Phantom Kit

GUDID B13628230

GAMMEX, INC.

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Primary Device ID	B13628230
NIH Device Record Key	225e2d86-d83c-4512-9fc0-90b034159167
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sun Nuclear MultiPHAN Phantom Kit
Version Model Number	2823
Company DUNS	157308230
Company Name	GAMMEX, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B13628230 [Primary]

FDA Product Code

LHO	Instrument, Quality-Assurance, Radiologic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-09-06
Device Publish Date	2021-08-27

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