GLIDESHEATH SLENDER TIBIAL PEDAL KIT

Basic Information

• Brand Name: GLIDESHEATH SLENDER TIBIAL PEDAL KIT
• Primary DI: 00389701012346
• Version / Model: 52-1050
• Catalog Number: 52-1050
• Company Name: TERUMO MEDICAL CORPORATION
• Labeler DUNS: 131489882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-13
• Public Version: 1
• Public Version Date: 2020-02-21
• Public Version Status: New
• Public Device Record Key: 009a41a2-0427-46b1-a7bb-3b0bda8b2be2

Device Description

GLIDESHEATH SLENDER Tibial Pedal Kit, 40mm

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: Yes
• 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	30389701012347	GS1	Shelfpack	5	In Commercial Distribution
Primary	00389701012346	GS1
Package	50389701012341	GS1	Carton	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Guidewire: 0.021 Inch x 43 Centimeter Nitinol
Device Size Text, specify			Needle: 21/19 gauge Tapered (0.8/1.1mm) x 1.575 in (40 mm)
Catheter Gauge	5	French
Length	10	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid direct sunlight. Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Do not store at extreme temperature and humidity