NA

Primary DI
00802526445286
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
6491
Device description
Lead Stylet, Standard
Published
2016-09-24
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

Related Records

Product Codes

CodeName
DRBSTYLET, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DRBStylet, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00802526445286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526445286008025264452868025264452860802526445286

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
106295384
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

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