NA

Primary DI
00613994505477
Brand
NA
Company
MEDTRONIC, INC.
Model
6057-45
Device description
STYLET 6057-45 GLBL STRGHT BALL TIPPED
Published
2016-04-02
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
P830061034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P830061034STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGMedtronic Cardiac Rhythm Disease Management1986-07-29NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994505477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994505477006139945054776139945054770613994505477

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter
Outer Diameter0.356Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

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00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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