Sentrant™

Basic Information

• Brand Name: Sentrant™
• Primary DI: 00763000716394
• Version / Model: SENSH1228W
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-21
• Public Version: 1
• Public Version Date: 2023-05-01
• Public Version Status: New
• Public Device Record Key: b974bd5c-21ba-4a9a-b225-c82c307899c8

Device Description

SENTRANT INTRODUCER SHEATH 12 FR X 28 CM

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: No
• 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
Primary	00763000716394	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171866	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Sheath size: 12FR
Guidewire Diameter	0.035	Inch
Device Size Text, specify			Sheath Working Length: 28CM

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the Sentrant introducer sheath at room temperature in a dark, dry place to avoid extended exposure to light and moisture.