AtriAmp - Pacing Cable

GUDID 10860004773716

Pacing Cable, 6FT, Medtronic® Connector

Atrility Medical LLC

Electrical-only medical device connection cable, single-use
Primary Device ID10860004773716
NIH Device Record Key60a8945e-4d80-4153-aecb-2d07af24b219
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtriAmp - Pacing Cable
Version Model Number10039
Company DUNS080558780
Company NameAtrility Medical LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004773719 [Primary]
GS110860004773716 [Package]
Contains: 00860004773719
Package: Carton [5 Units]
In Commercial Distribution
GS120860004773713 [Package]
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


[10860004773716]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-11
Device Publish Date2021-01-01

On-Brand Devices [AtriAmp - Pacing Cable]

00860004773726Pacing Cable, 6FT, 2mm Shrouded Connector
10860004773716Pacing Cable, 6FT, Medtronic® Connector

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