FDA.reportPublic FDA data

Steelex

Primary DI
04038653915415
Brand
Steelex
Company
B BRAUN SURGICAL SA
Model
C0992097
Catalog number
C0992097
Device description
STEELEX ELEC 2/0 (3) 60CM HR26/GS65V
Published
2015-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653915415PrimaryGS10
04046963064860Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653915415040386539154154038653915415
04046963064860040469630648604046963064860

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length60Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964732546MONOMAXB0041004B00410042018-05-03
04038653926190SteelexG0992100G09921002015-08-20
04046955081417OPTILENEB3095923B30959232022-10-04
04046955081653OPTILENEC3090272C30902722022-10-04
04046955081714OPTILENEC3090304C30903042022-10-04
04046964617331MONOSYNC2022015C20220152018-05-03
04046964618635MONOSYNC2022215C20222152018-05-03
04046964623615MONOSYNC2023424C20234242018-05-03
04046963043780DAFILONB0938920B09389202022-03-09
04046963117856DAFILONB0935890B09358902022-03-09
04046963929848DAFILONB0938905B09389052022-03-09
04046963042455DAFILONB0931640B09316402022-03-09
04046963043384DAFILONB0935739B09357392022-03-09
04038653945849SafilG1048388G10483882015-08-23
04046964028410MonomaxB9972005B99720052015-08-11
04046964028434MonomaxB9941967B99419672015-08-11
04046964028458MonomaxB9972004B99720042015-08-11
04046964028472MonomaxB9941966B99419662015-08-25
04046964066764MonomaxB9941249B99412492015-08-25
04046964066788MonomaxB9941258B99412582015-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056280006SoloPace Fusion Ground PadSOLO PACE INC.LDF2026-02-05
00836559001904Temporary Myocardial HeartwireOscor Inc.LDF2025-09-15
00836559001911Temporary Myocardial HeartwireOscor Inc.LDF2025-09-15
06947437902535MedtronicSHENZHEN LAUNCH ELECTRICAL CO., LTDLDF2025-02-08
20763000181080NAMEDTRONIC, INC.LDF2024-08-30
20801902216117ARROWTELEFLEX INCORPORATEDLDF2023-07-14
20801902198383ARROWTELEFLEX INCORPORATEDLDF2022-11-18
30836559004692Temporary Myocardial HeartwireOscor Inc.LDF2018-08-17
20884521757544FlexonCovidien LPLDF2018-08-10
20884521757551FlexonCovidien LPLDF2018-08-10
20884521757568FlexonCovidien LPLDF2018-08-10
20884521757575FlexonCovidien LPLDF2018-08-10
30705031245741E-PACKETHICON INC.LDF2018-05-10
30705031245697E-PACKETHICON INC.LDF2018-04-05
30705031242306E-PACKETHICON INC.LDF2017-12-06
30705031241859E-PACKETHICON INC.LDF2017-11-29
20836559004022Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
20836559004701Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
20885672102115Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001745Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001752Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001769Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001776Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001790Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001813Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001899Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559003992Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559004609Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559004616Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
00885672004347TBOscor Inc.LDF2017-11-27