Merit S-MAK™ S-MAK430NPD/A

GUDID 10884450410438

Merit Medical Systems, Inc.

Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use

Primary Device ID	10884450410438
NIH Device Record Key	95ee8343-e3ca-42e6-a01d-715346c3cebd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Merit S-MAK™
Version Model Number	00884450410431
Catalog Number	S-MAK430NPD/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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450410431 [Primary]
GS1	10884450410438 [Package] Contains: 00884450410431 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190175

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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-08-27
Device Publish Date	2019-08-19

On-Brand Devices [Merit S-MAK™]

10884450155070	00884450155073
10884450155063	00884450155066
10884450155049	00884450155042
10884450144463	00884450144466
10884450144456	00884450144459
10884450144449	00884450144442
10884450144432	00884450144435
10884450013295	00884450013298
10884450013288	00884450013281
10884450013271	00884450013274
10884450012861	00884450012864
10884450012663	00884450012666
10884450012656	00884450012659
10884450012649	00884450012642
10884450012632	00884450012635
10884450012625	00884450012628
10884450012618	00884450012611
10884450410438	00884450410431