Percutaneous Tract Kit

GUDID 08714729784432

Percutaneous Tract Kit

BOSTON SCIENTIFIC CORPORATION

Nephrostomy catheter
Primary Device ID08714729784432
NIH Device Record Key9065eacf-eeda-4bf0-a2d9-41fbccaad211
Commercial Distribution Discontinuation2024-02-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePercutaneous Tract Kit
Version Model NumberM0064501140
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729784432 [Primary]

FDA Product Code

OFCCatheter introducer kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-10-11
Device Publish Date2017-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729838005 - Capio SLIM2024-11-13 Suture Capturing Device
00191506043193 - FARAWAVE™ NAV2024-10-30 Pulsed Field Ablation Catheter
00191506043209 - FARAWAVE™ NAV2024-10-30 Pulsed Field Ablation Catheter
00191506043216 - FARAWAVE™2024-10-30 Pulsed Field Ablation Catheter
00191506043223 - FARAWAVE™2024-10-30 Pulsed Field Ablation Catheter
00191506043698 - FARASTAR™2024-10-30 Pulsed Field Ablation Generator
00191506043704 - FARASTAR™2024-10-30 Pulsed Field Ablation Generator
00191506043711 - FARASTAR™2024-10-30 Pulsed Field Ablation Generator

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.