FDA.reportPublic FDA data

S 75-K

Primary DI
04035479145194
Brand
S 75-K
Company
BIOTRONIK SE & Co. KG
Model
121197
Catalog number
121197
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
DRBSTYLET, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRBStylet, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191469000
P980023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191469000Biotronik StyletsBiotronik, Inc.2019-08-01DRB
P980023000PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479007485PackageGS110In Commercial Distribution
04035479145194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479007485040354790074854035479007485
04035479145194040354791451944035479145194

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
04035479194192PatientApp 2.10.05319975319972026-07-16
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20

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