Celero Introducer CELERO INTRO-12

GUDID 05420045503222

Hologic, Inc.

Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle
Primary Device ID05420045503222
NIH Device Record Key9b426050-850b-4b33-8415-1d3fd8b27192
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelero Introducer
Version Model NumberCELERO INTRO-12
Catalog NumberCELERO INTRO-12
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105420045503222 [Primary]
GS115420045503229 [Package]
Package: BOX [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05420045503222]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-11

Devices Manufactured by Hologic, Inc.

15420045509955 - Mammosite2024-05-03 Patient Care Kit
15420045509979 - Mammosite2024-05-03 CONTURA®/MAMMOSITE ACCESSORY KIT
15420045512948 - AFFIRM™ CONTRAST BIOPSY2024-04-19 Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dim
15420045511446 - Panther Fusion®2024-04-15 Epstein-Barr virus (EBV) Primers ASR.
15420045511453 - Panther Fusion®2024-04-15 Epstein-Barr virus (EBV) Probe ASR.
15420045511552 - Panther Fusion®2024-04-15 Hologic GAS Plasmid Control.
15420045511576 - Panther Fusion®2024-04-15 Group A Strep (GAS) Probe ASR.
15420045511590 - Panther Fusion®2024-04-15 Group A Strep (GAS) Primers ASR.
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.