SPINR™

GUDID 10884450277222

Merit Medical Systems, Inc.

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Primary Device ID	10884450277222
NIH Device Record Key	b9f7d40b-f5c8-4ecf-92a4-361e154c0ebe
Commercial Distribution Status	In Commercial Distribution
Brand Name	SPINR™
Version Model Number	00884450277225
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	00884450277225 [Primary]
GS1	10884450277222 [Package] Contains: 00884450277225 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141054

FDA Product Code

DQX	WIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-24

On-Brand Devices [SPINR™]

10884450277246	00884450277249
10884450277222	00884450277225