S 85-K OTW

Primary DI
04035479079062
Brand
S 85-K OTW
Company
BIOTRONIK SE & Co. KG
Model
346980
Catalog number
346980
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479079062PackageGS110In Commercial Distribution
04035479145231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479079062040354790790624035479079062
04035479145231040354791452314035479145231

GMDN Terms#

Term, Definition table
TermDefinition
Catheter styletA metal wire or flexible rod, typically with a plastic knob at the proximal end, that is inserted into the lumen of a catheter or cannula to provide internal reinforcement to increase the stiffness enough to facilitate manipulation and introduction into the body for various procedures. It is available in various lengths, diameters, and degrees of rigidity. Some types can include small passive magnets that generate a magnetic field which is detectable by an external catheter stylet magnet detector. 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
Sterilization required before use
false

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