Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7 0884-00-0019-22

GUDID 10607567108612

Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7.5Fr 40cc IAB

DATASCOPE CORP.

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Primary Device ID10607567108612
NIH Device Record Key4520ba1a-adb0-492e-97d7-c38a10f7e1a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7
Version Model Number0884-00-0019-22
Catalog Number0884-00-0019-22
Company DUNS001660786
Company NameDATASCOPE CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com

Device Dimensions

Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567108612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

[10607567108612]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

On-Brand Devices [Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7]

10607567108612Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7.5Fr 40cc IAB
10607567114231Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7.5Fr 40cc IAB
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