GUDID 00613994939845

CATH 6A0103 SS 5PK6F ANG KITW/145 XT 6SH

MEDTRONIC, INC.

Angiographic catheter, single-use Angiographic catheter, single-use
Primary Device ID00613994939845
NIH Device Record Key71443d7a-2db4-4789-8a0f-764140dd73b1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6A0103
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 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

Catheter Gauge6 French
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry area.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994939845 [Primary]
GS120613994939849 [Package]
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-20

Devices Manufactured by MEDTRONIC, INC.

00763000944322 - NA2024-04-23 CUSTOM PACK HY4953R31 MEMB PK
00763000944339 - NA2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK
00763000944346 - NA2024-04-23 CUSTOM PACK BB12F35R5 A PACK
00763000945558 - NA2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO
00763000943844 - NA2024-04-12 CUSTOM PACK BB11J59R5 PEDS
00763000943851 - NA2024-04-12 CUSTOM PACK BB12F35R3 A PACK
00763000943868 - NA2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
00763000943899 - NA2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.