SureCross SC3565/B

GUDID 10884450187712

Merit Medical Systems, Inc.

Angiographic catheter, single-use

Primary Device ID	10884450187712
NIH Device Record Key	c621f103-ef30-4173-a5d1-191f2684dd46
Commercial Distribution Status	In Commercial Distribution
Brand Name	SureCross
Version Model Number	00884450187715
Catalog Number	SC3565/B
Company DUNS	184763290
Company Name	Merit Medical Systems, 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	false
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	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450187715 [Primary]
GS1	10884450187712 [Package] Contains: 00884450187715 Package: [5 Units] In Commercial Distribution
GS1	20884450187719 [Package] Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123311

FDA Product Code

DQY	CATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-05

On-Brand Devices [SureCross]

10884450187750	00884450187753
20884450187740	00884450187746
10884450187736	00884450187739
10884450187712	00884450187715
20884450187696	00884450187692
10884450187637	00884450187630
10884450187620	00884450187623
20884450168510	00884450168516
20884450168503	00884450168509
10884450168490	00884450168493
20884450168480	00884450168486
20884450168473	00884450168479
20884450644847	C
20884450644830	C

Trademark Results [SureCross]

Mark Image Registration \| Serial	Company Trademark Application Date
SURECROSS 79251794 not registered Dead/Abandoned	ASAHI INTECC CO., LTD. 2018-11-19