Sublime™ Radial Access Guide Sheath

GUDID 05391525785127

CREAGH MEDICAL LIMITED

Vascular catheter introduction set, nonimplantable

Primary Device ID	05391525785127
NIH Device Record Key	91a5bb9d-f8ee-4efb-846c-7d665e22edd4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sublime™ Radial Access Guide Sheath
Version Model Number	SRA-GS35-5F120
Company DUNS	985021909
Company Name	CREAGH MEDICAL LIMITED
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	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Length	120 Centimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525785127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190644

FDA Product Code

DYB	Introducer, Catheter

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	2020-12-15
Device Publish Date	2020-12-07

On-Brand Devices [Sublime™ Radial Access Guide Sheath]

05391525785189	SRA-GS35-6F150
05391525785172	SRA-GS18-6F150
05391525785165	SRA-GS35-6F120
05391525785158	SRA-GS18-6F120
05391525785141	SRA-GS35-5F150
05391525785134	SRA-GS18-5F150
05391525785127	SRA-GS35-5F120
05391525785110	SRA-GS18-5F120

Trademark Results [Sublime]

Mark Image Registration \| Serial	Company Trademark Application Date
SUBLIME 98370049 not registered Live/Pending	Tiendas Tres B, S.A. de C.V. 2024-01-22
SUBLIME 98316782 not registered Live/Pending	Jake and Troy Brand LLC 2023-12-15
SUBLIME 98208169 not registered Live/Pending	Sublime Media LLC 2023-10-03
SUBLIME 98081252 not registered Live/Pending	2D Group Florida, LLC 2023-07-12
SUBLIME 97704107 not registered Live/Pending	Sublime Internet, Inc. 2022-12-05
SUBLIME 97286565 not registered Live/Pending	Transperfect Technologies LLC 2022-02-27
SUBLIME 97140002 not registered Live/Pending	Sublime Systems, Inc. 2021-11-23
SUBLIME 97139989 not registered Live/Pending	Sublime Systems, Inc. 2021-11-23
SUBLIME 97139123 not registered Live/Pending	Sublime Systems, Inc. 2021-11-23
SUBLIME 90831709 not registered Live/Pending	Win Technologies Limited 2021-07-15
SUBLIME 90829062 not registered Live/Pending	Ibitta Enterprises, Inc. 2021-07-14
SUBLIME 90790106 not registered Live/Pending	SOULMATE INDUSTRIES LIMITED 2021-06-23