SPIROFLEX 106553

GUDID 00616258003887

Thrombectomy suction catheter

Primary Device ID	00616258003887
NIH Device Record Key	bd30fdf3-3e8a-4482-9c72-7dbde2ce10ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	SPIROFLEX
Version Model Number	106553-001
Catalog Number	106553
Company DUNS	079415074
Company Name	Bayer Healthcare LLC
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	true
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
GS1	00616258003887 [Primary]

DXE	Catheter, Embolectomy

Steralize Prior To Use	false
Device Is Sterile	true

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Mark Image Registration \| Serial	Company Trademark Application Date
SPIROFLEX 78620655 3238159 Live/Registered	BOSTON SCIENTIFIC LIMITED 2005-05-02
SPIROFLEX 76413000 2888226 Dead/Cancelled	Spiroflex Limited 2002-05-29
SPIROFLEX 73471315 1311239 Dead/Cancelled	GMR Gymnastics Sales, Inc. 1984-03-21
SPIROFLEX 72357730 0941912 Live/Registered	LOHMANN & STOLTERFOHT AKTIENGESELLSCHAFT 1970-04-23