BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Instant Detacher

DI: 00763000290702 · Model: ID-1-5 · Micro Therapeutics, Inc.

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Product Codes

2

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Instant Detacher
Primary DI: 00763000290702
Version / Model: ID-1-5
Company Name: Micro Therapeutics, Inc.
Labeler DUNS: 826110710
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2023-01-30
Public Version: 3
Public Version Date: 2026-04-02
Public Version Status: Update
Public Device Record Key: ed9517a3-fc96-4aa2-9220-367c43412c2b

Device Description

Detacher ID-1-5 V02

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: Yes
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
KRD	Device, Vascular, for Promoting Embolization	Cardiovascular	870.3300	2
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION	Neurology	882.5950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66749	Vascular implant detacher, mechanical	A noninvasive, hand-held, manual device (non-electronic) intended to mechanically break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire). It is typically in the form of a handpiece, intended to be attached to the deployment device, with a mechanical switch for detachment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000290706	GS1	PK	5	In Commercial Distribution
Primary	00763000290702	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060747	000

Device Sizes

Type	Value	Unit	Text
Depth	6.6	Inch
Length	9.9	Inch
Height	4.0	Inch

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store in a dry place, away from sunlight.