Home GUDID 00763000812065
NA
Primary DI 00763000812065
Brand NA
Company MEDTRONIC, INC.
Model 5873W
Device description WRENCH KIT 5873W TORQUE STERILE MDR
Published 2024-03-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name DTF TOOLS, PACEMAKER SERVICE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTF Tools, Pacemaker Service Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00763000812065 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00763000812065 00763000812065 763000812065 0763000812065
GMDN Terms# Term, Definition table Term Definition Pacing/defibrillation lead repair kit A collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 006261481 Device count 1 Premarket exempt true Kit true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05414734504706 Merlin@home™ ST. JUDE MEDICAL, INC. DTF 2024-11-04 00763000059484 NA MEDTRONIC, INC. DTF 2018-12-22