Control 11F Mechanical Thrombectomy System, 60cm A11-060

GUDID B090A110601

General-purpose syringe, single-use

Primary Device ID	B090A110601
NIH Device Record Key	97b4531a-3a1d-4bc5-a87c-71c3f72e02d6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Control 11F Mechanical Thrombectomy System, 60cm
Version Model Number	A11-060
Catalog Number	A11-060
Company DUNS	017535668
Company Name	ZIEN MEDICAL TECHNOLOGIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B090A110600 [Primary]
HIBCC	B090A110601 [Package] Contains: B090A110600 Package: Shelf Carton [1 Units] In Commercial Distribution
HIBCC	B090A110602 [Package] Package: Shipper [9 Units] In Commercial Distribution

QEZ	Aspiration Thrombectomy Catheter

Steralize Prior To Use	false
Device Is Sterile	true

10850049994863 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var
10850049994870 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var
10850049994887 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var
10850049994894 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var
10850049994900 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent surgical sponge intended for use
10850049994917 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var
10850049994924 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var
10850049994931 - Syntervention	2025-10-06 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a var