Classic Sheath™ CLS-1009

GUDID 10884450163952

Merit Medical

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable

Primary Device ID	10884450163952
NIH Device Record Key	61a95ed8-f53e-4723-ad50-39198d4ed322
Commercial Distribution Status	In Commercial Distribution
Brand Name	Classic Sheath™
Version Model Number	10884450163952
Catalog Number	CLS-1009
Company DUNS	065673912
Company Name	Merit Medical
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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	00884450163955 [Unit of Use]
GS1	10884450163952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K934901

FDA Product Code

DYB	INTRODUCER, 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	4
Public Version Date	2019-06-07
Device Publish Date	2017-02-10

On-Brand Devices [Classic Sheath™]

10884450280963	00884450280966
10884450164119	00884450164112
10884450164072	00884450164075
10884450163891	00884450163894
10884450162917	00884450162910
10884450280949	10884450280949
10884450280925	10884450280925
10884450280901	10884450280901
10884450280888	10884450280888
10884450280864	10884450280864
10884450280840	10884450280840
10884450280826	10884450280826
10884450280802	10884450280802
10884450280789	10884450280789
10884450164201	10884450164201
10884450164164	10884450164164
10884450164157	10884450164157
10884450164133	10884450164133
10884450164058	10884450164058
10884450164041	10884450164041
10884450164027	10884450164027
10884450163990	10884450163990
10884450163983	10884450163983
10884450163969	10884450163969
10884450163952	10884450163952
10884450163938	10884450163938
10884450163921	10884450163921