FDA.reportPublic FDA data

Selectra Slitter

Primary DI
04035479124564
Brand
Selectra Slitter
Company
BIOTRONIK SE & Co. KG
Model
383119
Catalog number
383119
Published
2014-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479124564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479124564040354791245644035479124564

GMDN Terms#

Term, Definition table
TermDefinition
Catheter slitterA hand-held, surgical instrument used to facilitate the removal of an intravascularly placed catheter, typically a guide catheter used to introduce a variety of transvenous devices [e.g., a balloon catheter, oxygen (O2) and/or other sensors, pacing electrode/leads]. It has a specially shielded steel blade that is integrated into the handle. The exposed end of the transvenous device is typically placed and held in a protective channel of this device (the slitter) and the physician pulls the proximal end of the catheter against the blade in a smooth, firm, motion; this splits open the catheter hub and the tubing wall, leaving the transvenous device intact, in situ. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479177638BIOexpress4692984692982026-10-20
04035479190538SW HMSC 3.664980924980922026-05-28
04035479194406SW HMSC 3.685324265324262026-10-09
04035479190705NEO 2601.U4991024991022026-09-21
04035479190712PSW 2601.U4991034991032026-09-21
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008226ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008233ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008240ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008257ZebraQ'APEL MEDICAL LLCDQY2025-01-03