Del Medical/Universal

GUDID 00858340006264

An x-ray system component intended to be mounted to the floor, to support and facilitate position of the x-ray tube. The FMT18M does not allow for synchronized tracking and stitching.

Del Medical, Inc.

X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing
Primary Device ID00858340006264
NIH Device Record Key23d9f85a-3f8b-4d2d-af69-d4cd144e805e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDel Medical/Universal
Version Model NumberFMT18M
Company DUNS078671236
Company NameDel Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858340006264 [Primary]

FDA Product Code

IYBTube Mount, X-Ray, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-25
Device Publish Date2022-04-15

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