Merit Medical® 3339-31

GUDID 10884450019990

Merit Medical Systems, Inc.

Vascular dilator, single-use

• Primary Device ID: 10884450019990
• NIH Device Record Key: 8c076396-6195-49f2-9c8f-c1b91f3962d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merit Medical®
• Version Model Number: 00884450019993
• Catalog Number: 3339-31
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450019993 [Primary]
GS1	10884450019990 [Package]; Contains: 00884450019993; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801113

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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 [Merit Medical®]

• 00884450411469: 00884450411469
• 00884450411056: 00884450411056
• 00884450410820: 00884450410820
• 00884450410790: 00884450410790
• 00884450410769: 00884450410769
• 10884450410759: 00884450410752
• 00884450410318: 00884450410318
• 10884450410254: 00884450410257
• 00884450410196: 00884450410196
• 20884450410114: 00884450410110
• 10884450409920: 00884450409923
• 00884450409909: 00884450409909
• 20884450409613: 00884450409619
• 00884450409589: 00884450409589
• 00884450409572: 00884450409572
• 00884450409527: 00884450409527
• 00884450409459: 00884450409459
• 00884450409442: 00884450409442
• 00884450409435: 00884450409435
• 00884450409428: 00884450409428
• 00884450409411: 00884450409411
• 20884450409392: 00884450409398
• 00884450409381: 00884450409381
• 00884450409374: 00884450409374
• 00884450409305: 00884450409305
• 00884450409282: 00884450409282
• 20884450409255: 00884450409251
• 10884450409241: 00884450409244
• 00884450409213: 00884450409213
• 10884450409197: 00884450409190
• 20884450409187: 00884450409183
• 20884450409170: 00884450409176
• 10884450409135: 00884450409138
• 10884450409111: 00884450409114
• 00884450408964: 00884450408964
• 00884450408940: 00884450408940
• 00884450408933: 00884450408933
• 00884450408766: 00884450408766
• 00884450408759: 00884450408759
• 10884450408749: 00884450408742
• 00884450408735: 00884450408735
• 20884450408678: 00884450408674
• 00884450408667: 00884450408667
• 00884450408285: 00884450408285
• 10884450408275: 00884450408278
• 00884450408261: 00884450408261
• 00884450408247: 00884450408247
• 00884450408230: 00884450408230
• 20884450408111: 00884450408117
• 10884450408084: 00884450408087