Micronitinol Rapid Access Kit

Basic Information

• Brand Name: Micronitinol Rapid Access Kit
• Primary DI: 00821329400599
• Version / Model: 10842‐002
• Catalog Number: 900120‐01
• Company Name: Greatbatch Ltd
• Labeler DUNS: 968623467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-06
• Public Version: 3
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 9ddc418e-2a84-47ed-ba1b-a65f2f151dd9

Device Description

Micronitinol Rapid Access Coaxial Introducer Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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	00821329400599	GS1
Package	10821329400596	GS1		5	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Length	9.3	Centimeter