Softouch® 4408-2M65SH

GUDID 10884450010140

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: 10884450010140
• NIH Device Record Key: 2c13e78c-8535-4e94-b82c-17cbdd30129e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Softouch®
• Version Model Number: 00884450010143
• Catalog Number: 4408-2M65SH
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450010143 [Primary]
GS1	10884450010140 [Package]; Contains: 00884450010143; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000659

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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 [Softouch®]

• 10884450294540: 00884450294543
• 10884450294502: 00884450294505
• 10884450283322: 00884450283325
• 10884450283315: 00884450283318
• 10884450283285: 00884450283288
• 10884450283261: 00884450283264
• 10884450283124: 00884450283127
• 10884450251185: 00884450251188
• 10884450251178: 00884450251171
• 10884450251147: 00884450251140
• 10884450232498: 00884450232491
• 10884450207670: 00884450207673
• 10884450207144: 00884450207147
• 10884450207120: 00884450207123
• 10884450168131: 00884450168134
• 10884450145729: 00884450145722
• 10884450122850: 00884450122853
• 10884450082628: 00884450082621
• 10884450082598: 00884450082591
• 10884450076030: 00884450076033
• 10884450073435: 00884450073438
• 10884450073428: 00884450073421
• 10884450067618: 00884450067611
• 10884450066550: 00884450066553
• 10884450066420: 00884450066423
• 10884450066413: 00884450066416
• 10884450066406: 00884450066409
• 10884450066352: 00884450066355
• 10884450063320: 00884450063323
• 10884450063290: 00884450063293
• 10884450063276: 00884450063279
• 10884450062156: 00884450062159
• 10884450040604: 00884450040607
• 10884450040451: 00884450040454
• 10884450040444: 00884450040447
• 10884450040437: 00884450040430
• 10884450040406: 00884450040409
• 10884450040390: 00884450040393
• 10884450026509: 00884450026502
• 10884450010140: 00884450010143
• 10884450003104: 00884450003107
• 10884450003098: 00884450003091
• 10884450003081: 00884450003084