DEVICE: SJM™ (05414734503792)
Device Identifier (DI) Information
SJM™
DS06002/60
Not in Commercial Distribution
DS06002/60
ST. JUDE MEDICAL, INC.
DS06002/60
Not in Commercial Distribution
DS06002/60
ST. JUDE MEDICAL, INC.
STYLET KIT (Compatible with Brady/Tachy SJM™ leads)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46717 | Pacing/defibrillation lead stylet |
A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRB | STYLET, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Storage Environment Temperature: between -5 and 50 Degrees Celsius |
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between -5 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 60 Centimeter |
Device Record Status
b5c2af8f-c402-4295-b979-9196cf28ddf1
October 19, 2020
4
November 23, 2015
October 19, 2020
4
November 23, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com