GUDID 00721902015946

NEEDLE EP003997S BROCKEN 56CM STER 10L

MEDTRONIC, INC.

Cardiac transseptal needle
Primary Device ID00721902015946
NIH Device Record Key03e49aa7-04e3-47b5-b159-57aa21632d6d
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberEP003997S
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter0.912 Millimeter
Outer Diameter0.912 Millimeter
Outer Diameter0.912 Millimeter
Outer Diameter0.912 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902015946 [Primary]

FDA Product Code

DRCTrocar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-28
Device Publish Date2016-04-23

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