ATEC 0914-20MR ATEC 0914-20MR

GUDID 15420045504899

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 Side-notch biopsy gun handpiece/needle
Primary Device ID15420045504899
NIH Device Record Key9ba819c4-7f5e-418a-b501-d547a290eb22
Commercial Distribution StatusIn Commercial Distribution
Brand NameATEC 0914-20MR
Version Model NumberATEC 0914-20MR
Catalog NumberATEC 0914-20MR
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
GS115420045504899 [Primary]
GS125420045504896 [Package]
Package: BOX [5 Units]
In Commercial Distribution
GS135420045504893 [Package]
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15420045504899]

Radiation Sterilization

[15420045504899]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-26

Devices Manufactured by Hologic, Inc.

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.
15420045512122 - Panther Fusion®2024-04-15 Hologic EBV Plasmid Control.
15420045515529 - OMNI2024-02-27 The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.