NA

Basic Information

• Brand Name: NA
• Primary DI: 00836462011045
• Version / Model: ID-1-5
• Catalog Number: ID-1-5
• Company Name: Micro Therapeutics, Inc.
• Labeler DUNS: 826110710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 92993d45-a768-435f-b0d5-ed21e498c436

Device Description

Instant Detacher

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: MR Conditional
• 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
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION	Neurology	882.5950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43978	Embolization implant inserter	A long, thin, manual surgical device intended to advance an embolization implant (e.g. an embolic coil) through the length of an appropriate catheter so that the implant is ready for discharge (implantation) when the catheter has been surgically positioned at the target site in an artery or vein. The inserter, also known as a pusher, is removed prior to discharge of the implant. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00836462011045	GS1
Unit of Use	10884521547063	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060747	000