GUDID 00613994505484

STYLET 6057-110 GLBL STRGHT BALL TIPPED

MEDTRONIC, INC.

Catheter stylet
Primary Device ID00613994505484
NIH Device Record Key8f33cf1e-d9f7-4492-8576-6d38db1afccb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6057-110
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter
Outer Diameter0.356 Millimeter
Length110 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994505484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRBSTYLET, CATHETER

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 Date2016-04-02

Devices Manufactured by MEDTRONIC, INC.

20199150023800 - NA2025-06-09 CUSTOM PACK BB11X70R1 5PK AV LOOP
20199150023824 - NA2025-06-09 CUSTOM PACK BB8A44R4 4PK HBC MYO
20199150024135 - NA2025-06-09 CUSTOM PACK BB11A07R2 5PK BRIDGE LINE
00613994163523 - Duran AnCore2025-06-09 TOOL 7620HXL HANDLE DURAN ANCORE 14L
00613994959546 - Open Pivot™2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG
00643169402539 - MOSAIC ULTRA™2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L
00643169402591 - MOSAIC™CINCH™2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L
00643169525511 - CG Future™2025-06-09 SIZER SET 7638S CG FUTURE 26L

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.