815012US 815012US

GUDID 25420045505398

Hologic, Inc.

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
Primary Device ID25420045505398
NIH Device Record Key4dcca622-4c17-45e0-8cfc-0d02ff2d8fb2
Commercial Distribution StatusIn Commercial Distribution
Brand Name815012US
Version Model Number815012US
Catalog Number815012US
Company DUNS018925968
Company NameHologic, Inc.
Device Count5
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS115420045505391 [Unit of Use]
GS125420045505398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDEVICE, THERMAL ABLATION, ENDOMETRIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-08

Devices Manufactured by Hologic, Inc.

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15420045517073 - Aptima®2024-12-27 Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificatio
15420045517080 - Aptima®2024-12-27 Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificat
15420045506411 - ATEC2024-10-24
15420045506428 - ATEC2024-10-24
15420045516144 - Fluent Pro Procedure Kit2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy
15420045516113 - Fluent Pro Waste Bag2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy

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