GUDID 00763000058975

STYLET 6057-110 STRGHT BALL GLBL EIFU

MEDTRONIC, INC.

Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet
Primary Device ID00763000058975
NIH Device Record Key10f8ebeb-a576-4d9a-b9cd-6a8d0b8471d3
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

Device Dimensions

Outer Diameter0.014 Inch
Outer Diameter0.014 Inch
Outer Diameter0.014 Inch
Outer Diameter0.014 Inch
Outer Diameter0.014 Inch
Outer Diameter0.014 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000058975 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-19
Device Publish Date2018-08-19

Devices Manufactured by MEDTRONIC, INC.

00763000951825 - NA2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL
00763000953423 - NA2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK
00763000953614 - NA2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK

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