FDA.reportPublic FDA data

S 60-C

Primary DI
04035479145040
Brand
S 60-C
Company
BIOTRONIK SE & Co. KG
Model
359223
Catalog number
359223
Published
2014-08-01
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
DRBSTYLET, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRBStylet, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191469000
P980023037

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191469000Biotronik StyletsBiotronik, Inc.2019-08-01DRB
P980023037PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479100650PackageGS110In Commercial Distribution
04035479145040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479100650040354791006504035479100650
04035479145040040354791450404035479145040

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter styletA thin sterile wire intended to be inserted within the lumen of a vascular catheter [e.g., peripheraly inserted venous catheter (PICC)] to stiffen and/or maintain the shape of the catheter to facilitate insertion; it is not intended for introduction into the coronary vasculature. It may be magnetic to enable use with a magnetic tracking system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

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
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376164Liberator®Merit Medical Systems, Inc.DRB2026-05-13
00763000760557NAMEDTRONIC, INC.DRB2024-05-05
00763000760564NAMEDTRONIC, INC.DRB2024-05-05
00763000760571NAMEDTRONIC, INC.DRB2024-05-05
00763000760588NAMEDTRONIC, INC.DRB2024-05-05
00763000760595NAMEDTRONIC, INC.DRB2024-05-05
00763000760601NAMEDTRONIC, INC.DRB2024-05-05
00763000760618NAMEDTRONIC, INC.DRB2024-05-05
00763000760625NAMEDTRONIC, INC.DRB2024-05-05
00763000760632NAMEDTRONIC, INC.DRB2024-05-05
00763000760649NAMEDTRONIC, INC.DRB2024-05-05
00763000760656NAMEDTRONIC, INC.DRB2024-05-05
00763000760663NAMEDTRONIC, INC.DRB2024-05-05
00763000760670NAMEDTRONIC, INC.DRB2024-05-05
00763000760687NAMEDTRONIC, INC.DRB2024-05-05
00763000760694NAMEDTRONIC, INC.DRB2024-05-05
00763000760700NAMEDTRONIC, INC.DRB2024-05-05
00763000760717NAMEDTRONIC, INC.DRB2024-05-05
00763000760724NAMEDTRONIC, INC.DRB2024-05-05
00763000760731NAMEDTRONIC, INC.DRB2024-05-05
00763000760748NAMEDTRONIC, INC.DRB2024-05-05
00763000760755NAMEDTRONIC, INC.DRB2024-05-05
00763000760762NAMEDTRONIC, INC.DRB2024-05-05
00763000760779NAMEDTRONIC, INC.DRB2024-05-05
00763000760786NAMEDTRONIC, INC.DRB2024-05-05
00763000760793NAMEDTRONIC, INC.DRB2024-05-05
00763000569075N/AMEDTRONIC, INC.DRB2024-05-04
00763000569082N/AMEDTRONIC, INC.DRB2024-05-04
00763000569099N/AMEDTRONIC, INC.DRB2024-05-04
00763000569105N/AMEDTRONIC, INC.DRB2024-05-04