TRIDENT HD SPECIMEN RADIOGRAPHY

GUDID 15420045510425

Hologic, Inc.

Specimen x-ray system IVD
Primary Device ID15420045510425
NIH Device Record Key11111656-c373-4ce5-a1e4-5af5afa584b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIDENT HD SPECIMEN RADIOGRAPHY
Version Model NumberTRI-00002
Company DUNS139534114
Company NameHologic, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS115420045510425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWPCabinet, x-ray system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-12
Device Publish Date2020-03-04

On-Brand Devices [TRIDENT HD SPECIMEN RADIOGRAPHY]

15420045512214TRI-00002
15420045510425TRI-00002

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