SafeSheath™ FCL-022-04

GUDID 10884450281113

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

Primary Device ID	10884450281113
NIH Device Record Key	499f8ff5-1a72-4fe3-9917-a776401b341e
Commercial Distribution Status	In Commercial Distribution
Brand Name	SafeSheath™
Version Model Number	00884450281116
Catalog Number	FCL-022-04
Company DUNS	065673912
Company Name	Merit Medical
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	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	00884450281116 [Primary]
GS1	10884450281113 [Package] Contains: 00884450281116 Package: [5 Units] In Commercial Distribution

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	2017-03-27

On-Brand Devices [SafeSheath™]

10884450396077	00884450396070
10884450396060	00884450396063
10884450396046	00884450396049
10884450396039	00884450396032
10884450396022	00884450396025
10884450396015	00884450396018
10884450396008	00884450396001
10884450395995	00884450395998
10884450395988	00884450395981
10884450395971	00884450395974
10884450395964	00884450395967
10884450395957	00884450395950
10884450395940	00884450395943
10884450281496	00884450281499
10884450281489	00884450281482
10884450281472	00884450281475
10884450281465	00884450281468
10884450281458	00884450281451
10884450281441	00884450281444
10884450281397	00884450281390
10884450281366	00884450281369
10884450281359	00884450281352
10884450281342	00884450281345
10884450281335	00884450281338
10884450281328	00884450281321
10884450281311	00884450281314
10884450281304	00884450281307
10884450281298	00884450281291
10884450281120	00884450281123
10884450281113	00884450281116
10884450281106	00884450281109
10884450281373	10884450281373
10884450281199	10884450281199
10884450281090	10884450281090