Micro-Access Tearaway Introducer Kit

Basic Information

• Brand Name: Micro-Access Tearaway Introducer Kit
• Primary DI: 00841268105331
• Version / Model: KIT-010-31
• Catalog Number: KIT-010-31
• Company Name: GALT MEDICAL CORP.
• Labeler DUNS: 943156836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-06
• Public Version: 4
• Public Version Date: 2020-12-15
• Public Version Status: Update
• Public Device Record Key: 46b14143-3459-4725-8c9b-9d109a3c1997
• Distribution End Date: 2020-12-14

Device Description

Micro-Access Tearaway 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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFL	Percutaneous Sheath Introducer Kit	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	20841268105335	GS1	Shipper Box	50	Not in Commercial Distribution	2020-12-14
Package	10841268105338	GS1	Shelf Box	5	Not in Commercial Distribution	2020-12-14
Primary	00841268105331	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	3.5	French