NA

Primary DI
00613994618702
Brand
NA
Company
MEDTRONIC, INC.
Model
625485
Device description
STYLET 625485 US DS KNOB ST
Published
2016-04-01
Public version status
Update
Distribution status
Not 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
K010906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010906000MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254Medtronic Vascular2001-04-05DRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994618706PackageGS15Not in Commercial Distribution
00613994618702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399461870620613994618706
00613994618702006139946187026139946187020613994618702

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead styletA sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length85Centimeter
Outer Diameter0.406Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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