Coil Pusher-16 M0014012160

GUDID 08714729158967

Coil Pusher-16

BOSTON SCIENTIFIC CORPORATION

Embolization implant inserter
Primary Device ID08714729158967
NIH Device Record Keyc084bbaa-af78-47c6-a584-252b27e4d30f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoil Pusher-16
Version Model NumberM0014012160
Catalog NumberM0014012160
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729158967 [Primary]

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2015-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

00802526627903 - LATITUDE™ Programming System2026-01-29 Programming System
00191506043964 - FARASTAR™2026-01-28 EGM to EP Recording System Cable (FARAPOINT™)
00191506047207 - FARAPOINT™2026-01-28 Pulsed Field Ablation Catheter
00191506047221 - FARAPOINT™2026-01-28 Pulsed Field Ablation Catheter
00191506055073 - FARASTAR™2026-01-28 Inter-Connection Box
00191506057688 - FARASTAR™2026-01-28 Pulsed Field Ablation Generator
08714729780489 - Blazer™ Dx-202026-01-21 Bidirectional Steerable Diagnostic Catheter
08714729780496 - Blazer™ Dx-202026-01-21 Bidirectional Steerable Diagnostic Catheter

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.