FDA.reportPublic FDA data

S 53-S

Primary DI
04035479018337
Brand
S 53-S
Company
BIOTRONIK SE & Co. KG
Model
130013
Catalog number
130013
Published
2014-08-14
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
DRBSTYLET, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRBStylet, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191469000Biotronik StyletsBiotronik, Inc.2019-08-01DRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479018337PackageGS110In Commercial Distribution
04035479145026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479018337040354790183374035479018337
04035479145026040354791450264035479145026

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

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
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
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