DEVICE: Steelex (04038653915392)
Device Identifier (DI) Information
Steelex
C0992046
In Commercial Distribution
C0992046
B BRAUN SURGICAL SA
C0992046
In Commercial Distribution
C0992046
B BRAUN SURGICAL SA
STEELEX ELEC 3/0 (2) 60CM HR26/GS65V
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? |
---|---|---|---|---|
47852 | Temporary cardiac pacing catheter |
A sterile, flexible tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LDF | ELECTRODE, PACEMAKER, TEMPORARY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -20 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Size of Thread (USP - Others) : 3/0 |
Device Size Text, specify: Thread Material : stainless steel |
Length: 60 Centimeter |
Device Record Status
276b4ff7-ac67-43d9-87ba-8cd569b32d18
April 28, 2022
11
August 16, 2015
April 28, 2022
11
August 16, 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:
04046963064822
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com