GLIDESHEATH SLENDER

Basic Information

• Brand Name: GLIDESHEATH SLENDER
• Primary DI: 04987350722645
• Version / Model: RM*ES5F10HAU
• Catalog Number: RM*ES5F10HAU
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: fbcc241d-6a86-4a52-a38d-74ae59b48f8b
• Distribution End Date: 2018-07-31

Device Description

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34987350722646	GS1	Shelfbox	5	Not in Commercial Distribution	2018-07-31
Primary	04987350722645	GS1
Package	54987350722640	GS1	Carton	4	Not in Commercial Distribution	2018-07-31

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	1.78	Millimeter
Device Size Text, specify			Those Clinically Relevant Size are relative to the sheath.
Length	10	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 11.