ConcierGE Guiding Excellence™ CGC5100JL35ST/A

GUDID 00884450036327

Merit Medical Systems, Inc.

Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use

• Primary Device ID: 00884450036327
• NIH Device Record Key: b02b70b2-7430-4c24-adba-29540c49dd9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConcierGE Guiding Excellence™
• Version Model Number: 00884450036327
• Catalog Number: CGC5100JL35ST/A
• 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: 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: false
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450036327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132409

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: 2016-09-24

On-Brand Devices [ConcierGE Guiding Excellence™]

• 00884450326152: 00884450326152
• 00884450326138: 00884450326138
• 00884450326121: 00884450326121
• 00884450326114: 00884450326114
• 00884450326107: 00884450326107
• 00884450248461: 00884450248461
• 00884450248454: 00884450248454
• 00884450248447: 00884450248447
• 00884450248430: 00884450248430
• 00884450246160: 00884450246160
• 00884450246153: 00884450246153
• 00884450246139: 00884450246139
• 00884450246122: 00884450246122
• 00884450246115: 00884450246115
• 00884450246108: 00884450246108
• 00884450246078: 00884450246078
• 00884450246061: 00884450246061
• 00884450246054: 00884450246054
• 00884450246016: 00884450246016
• 00884450245996: 00884450245996
• 00884450245972: 00884450245972
• 00884450242995: 00884450242995
• 00884450242988: 00884450242988
• 00884450242865: 00884450242865
• 00884450242841: 00884450242841
• 00884450242834: 00884450242834
• 00884450242827: 00884450242827
• 00884450242810: 00884450242810
• 00884450242803: 00884450242803
• 00884450242797: 00884450242797
• 00884450242698: 00884450242698
• 00884450242681: 00884450242681
• 00884450242674: 00884450242674
• 00884450242667: 00884450242667
• 00884450242650: 00884450242650
• 00884450242643: 00884450242643
• 00884450242636: 00884450242636
• 00884450242629: 00884450242629
• 00884450242612: 00884450242612
• 00884450242605: 00884450242605
• 00884450242599: 00884450242599
• 00884450242582: 00884450242582
• 00884450242575: 00884450242575
• 00884450242568: 00884450242568
• 00884450242551: 00884450242551
• 00884450242544: 00884450242544
• 00884450242537: 00884450242537
• 00884450242520: 00884450242520
• 00884450242513: 00884450242513
• 00884450242506: 00884450242506